The document discusses conducting clinical trials in Latin America. It provides an overview of key considerations for investigators, sites, patients, the regulatory environment, and common challenges and suggestions for success. Specific topics covered include investigator experience and training, public vs private sites and locations, patient standards of care, epidemiology, regulatory timelines and processes, informed consent requirements, and regional requirements regarding comparators and continued treatment.
Latin America: Challenges & Opportunities in Clinical ResearchMedpace
With an established regulatory environment and a strong healthcare infrastructure, Latin America continues to grow as an advantageous landscape for conducting clinical research. Join Medpace experts Anibal Calmaggi, MD, Senior Medical Director, Infectious Diseases and Vaccines, and Wanda Dobrzanski, MD, Director Clinical Operations, Pediatric infectious diseases and Pharmaceutical medicine specialist, as they share their collective 36 years of experience in designing and managing clinical research in Latin America.
This presentation discusses:
• Advantages and benefits of running trials in Latin America
• Challenges and strategies for addressing them
• Required procedures and processes
• An in-depth look at the most significant Latin American countries for conducting clinical research
Latin America provides opportunities for clinical research due to its large, diverse population concentrated in major cities. The region has two main languages and a growing pharmaceutical market projected to reach $80 billion by 2013. Countries like Brazil, Argentina, and Chile form the large Southern Cone market and have quality clinical research environments with experienced regulators following ICH-GCP guidelines. However, some challenges remain like improving ethics review, dedicated research infrastructure, and lengthy government approval processes. Overall, Latin America's lower costs and unique patient populations make it an attractive region for recruitment in clinical trials.
Netherland medical devices compliance update Erik Vollebregt
The document summarizes recent developments regarding compliance with regulations on interactions between the medical device industry and healthcare professionals in the Netherlands. Specifically, it discusses:
1) An agreement by hospitals and doctors' associations to comply with the Dutch code on gifts and hospitality from industry, though some professional groups have not agreed yet.
2) The Dutch government lobbying for stronger enforcement tools regarding healthcare professional interactions in proposed EU regulations, but it is unclear if this will be included.
3) Planned amendments to Dutch law to allow the competent authority to enforce regulations on industry gifts and hospitality, analogous to rules for pharmaceutical companies. The changes could take effect in 2016.
Clinical research in Latin America: constraints and opportunitiesCER Clinical Trials
The number of patients enrolled in international multi-centre clinical trials has increased in some countries of Latin America. Eduardo Gotuzzo, M.D. FACP
Brazil International Ltd. is a boutique company that provides business
services for companies in the medical device field, seeking to
successfully penetrate and participate in the Brazilian market.
Clinical trials in Latin America face regulatory frameworks that vary by country. While countries like Argentina, Brazil, and Mexico have adopted international good clinical practice guidelines, regulatory approval processes can be lengthy, requiring documents translated to the local language and approvals from both local and national ethics boards. Common challenges include economic instability, intellectual property protection, and health care access and costs. Strategies for successful clinical trials in the region include early planning, partnering with experienced local clinical research organizations, and consulting regulatory experts from within each country.
Taiwan medical device registration and approval chart - EMERGOEMERGO
Taiwan regulates medical devices through the Pharmaceutical Affairs Act and Regulations for Governing the Management of Medical Devices. The process involves classifying the device, appointing a Taiwan agent, preparing quality system documentation for submission, and obtaining approval. Device classification and complexity of approval requirements vary, with Class I generally having the simplest process taking 1-2 months, Class II taking 10-12 months, and Class III taking 10-12 months and requiring a committee review.
Mexico has a large pharmaceutical market worth $13 billion. COFEPRIS is the regulatory authority that oversees drug approval and GMP inspections. Drug registration requires extensive documentation and can take 12-24 months. Local clinical trials may be required. New detailed regulations were introduced in 2012 to regulate biologics and biosimilars. GMP inspections by COFEPRIS of manufacturing sites are required for new drug approvals and changes and can take around 3 months to arrange.
Latin America: Challenges & Opportunities in Clinical ResearchMedpace
With an established regulatory environment and a strong healthcare infrastructure, Latin America continues to grow as an advantageous landscape for conducting clinical research. Join Medpace experts Anibal Calmaggi, MD, Senior Medical Director, Infectious Diseases and Vaccines, and Wanda Dobrzanski, MD, Director Clinical Operations, Pediatric infectious diseases and Pharmaceutical medicine specialist, as they share their collective 36 years of experience in designing and managing clinical research in Latin America.
This presentation discusses:
• Advantages and benefits of running trials in Latin America
• Challenges and strategies for addressing them
• Required procedures and processes
• An in-depth look at the most significant Latin American countries for conducting clinical research
Latin America provides opportunities for clinical research due to its large, diverse population concentrated in major cities. The region has two main languages and a growing pharmaceutical market projected to reach $80 billion by 2013. Countries like Brazil, Argentina, and Chile form the large Southern Cone market and have quality clinical research environments with experienced regulators following ICH-GCP guidelines. However, some challenges remain like improving ethics review, dedicated research infrastructure, and lengthy government approval processes. Overall, Latin America's lower costs and unique patient populations make it an attractive region for recruitment in clinical trials.
Netherland medical devices compliance update Erik Vollebregt
The document summarizes recent developments regarding compliance with regulations on interactions between the medical device industry and healthcare professionals in the Netherlands. Specifically, it discusses:
1) An agreement by hospitals and doctors' associations to comply with the Dutch code on gifts and hospitality from industry, though some professional groups have not agreed yet.
2) The Dutch government lobbying for stronger enforcement tools regarding healthcare professional interactions in proposed EU regulations, but it is unclear if this will be included.
3) Planned amendments to Dutch law to allow the competent authority to enforce regulations on industry gifts and hospitality, analogous to rules for pharmaceutical companies. The changes could take effect in 2016.
Clinical research in Latin America: constraints and opportunitiesCER Clinical Trials
The number of patients enrolled in international multi-centre clinical trials has increased in some countries of Latin America. Eduardo Gotuzzo, M.D. FACP
Brazil International Ltd. is a boutique company that provides business
services for companies in the medical device field, seeking to
successfully penetrate and participate in the Brazilian market.
Clinical trials in Latin America face regulatory frameworks that vary by country. While countries like Argentina, Brazil, and Mexico have adopted international good clinical practice guidelines, regulatory approval processes can be lengthy, requiring documents translated to the local language and approvals from both local and national ethics boards. Common challenges include economic instability, intellectual property protection, and health care access and costs. Strategies for successful clinical trials in the region include early planning, partnering with experienced local clinical research organizations, and consulting regulatory experts from within each country.
Taiwan medical device registration and approval chart - EMERGOEMERGO
Taiwan regulates medical devices through the Pharmaceutical Affairs Act and Regulations for Governing the Management of Medical Devices. The process involves classifying the device, appointing a Taiwan agent, preparing quality system documentation for submission, and obtaining approval. Device classification and complexity of approval requirements vary, with Class I generally having the simplest process taking 1-2 months, Class II taking 10-12 months, and Class III taking 10-12 months and requiring a committee review.
Mexico has a large pharmaceutical market worth $13 billion. COFEPRIS is the regulatory authority that oversees drug approval and GMP inspections. Drug registration requires extensive documentation and can take 12-24 months. Local clinical trials may be required. New detailed regulations were introduced in 2012 to regulate biologics and biosimilars. GMP inspections by COFEPRIS of manufacturing sites are required for new drug approvals and changes and can take around 3 months to arrange.
Saudi arabia medical device regulatory processEMERGO
To market medical devices in Saudi Arabia, devices must receive marketing authorization from the Saudi Food and Drug Authority (SFDA). The SFDA application is reviewed for completeness then sent to a third party for technical review, which can involve multiple rounds of questions. Once approved, the SFDA issues a certificate allowing marketing in Saudi Arabia. Appointing an authorized local representative is also required to manage the registration process. Overall, registration times range from 1-6 months but costs and complexity vary depending on the device's risk classification.
ANVISA is the Brazilian Health Surveillance Agency established in 1999 to coordinate the National Sanitary Surveillance System and other health programs. It is responsible for regulating drugs, medical devices, food, cosmetics and other products. ANVISA monitors prices, conducts inspections, and provides technical support. It aims to protect public health through sanitary control of production, marketing and borders. ANVISA is part of the decentralized National System of Sanitary Surveillance and works with various federal, state and municipal agencies.
Chinese Food and Drug Administration (CFDA) Regulatory Approval Process: Medi...NAMSA
The document summarizes China's regulatory approval process for medical devices. It outlines the testing process manufacturers must go through, including writing custom product standards and undergoing variable performance testing at CFDA-designated sites. Recent changes require Class I devices to file documentation rather than register, and Class II and III devices to conduct clinical trials for approval, with some exceptions. IVD registration requirements also changed, with Class I through filing, and Classes II and III requiring registration and trials.
The document summarizes key information about Argentina's economy, healthcare system, and pharmaceutical industry and regulations.
1) Argentina has a $435.6 billion GDP, ranks 27th in the world and 3rd in Latin America. It has an annual growth rate of 8.8%, ranking 12th globally and 1st in Latin America. Services make up 60% of GDP, industry 30%, and agriculture 10%.
2) Healthcare spending is 8.5% of GDP, with 48% covered by social security and 9% by voluntary insurance. The top therapeutic areas are nervous system, cardiovascular, and digestive disorders. 38% have no healthcare coverage.
3) Drug regulation is overseen by the National Administration
This document provides information about ANVISA, the National Health Surveillance Agency of Brazil. Some key points:
- ANVISA is the regulatory body that oversees pharmaceuticals, cosmetics, medical devices and other health products in Brazil. It was established in 1999.
- ANVISA's mission is to protect and promote public health by ensuring safety and quality standards for products and services.
- It is responsible for monitoring drug prices, medical device approval, tobacco control and more. ANVISA works with the Brazilian Ministry of Health.
- Detailed guidelines are provided around the registration of new drugs, generic drugs, medical devices and other regulated products in Brazil according to ANVISA's
Strategies and Opportunities of Outsourcing -Product Development and Manufact...daisyrmuzzio
This document discusses strategies and opportunities for outsourcing pharmaceutical product development and manufacturing services from Latin America. It notes that Latin America has the potential to become a key global outsourcing hub for these activities in the next 5-10 years due to benefits like industry growth, innovation, and capabilities to address local health needs. It highlights several Latin American countries' strengths in areas like clinical research capabilities, manufacturing infrastructure, and a growing biotech industry. It also discusses expectations for the region to close gaps in areas like regulatory environments and intellectual property protections.
The document provides information on regulatory submissions in Japan. It discusses:
- Japan's pharmaceutical market size and aging population trends.
- The Ministry of Health and Pharmaceutical and Medical Devices Agency (PMDA) oversee drug regulation. Applications are submitted to PMDA for approval.
- The Common Technical Document (CTD) format is used for submissions, which organizes information into five modules covering administrative data, summaries, quality, nonclinical studies, and clinical studies.
Changes in device classification under the EU Medical Devices and In Vitro Di...Erik Vollebregt
Presentation at the Q1 Intensive MDR/IVDR Readiness
and Transition Management Workshop about classification changes under the EU Medical Devices and In Vitro Diagnostic Regulation
Strategies for Device Approval in China, India, South Korea and AustraliaApril Bright
This session will describe the orthopaedic device regulatory and registration requirements in Asia Pacific markets. Regulatory steps and strategies will be presented for each of these countries. The discussion will also cover ways to gain regulatory information about competitors already selling in these markets. Attendees will leave the session with an understanding of timelines, costs and complexity for approval.
Europe CE Marking for medical devices under new MDREMERGO
Starting in early 2020, medical devices seeking CE Marking certification in Europe must comply with the new Medical Device Regulation (MDR). This will require appointing personnel responsible for regulatory compliance, classifying the device, appointing an Authorized Representative located in the EU, including labeling with this information, and obtaining a Single Registration Number. Manufacturers must also prepare technical documentation, implement a quality management system, and undergo annual audits by a Notified Body to maintain certification.
Argentina has a population of 40 million people and a growing economy, with GDP of $435.6 billion. The pharmaceutical industry in Argentina generates around $4 billion in revenue per year.
The regulatory authority for drugs in Argentina is ANMAT (National Administration of Drugs, Food and Medical Technology). Drug registration pathways depend on where the drug is manufactured - drugs manufactured in Annex I countries (countries with high regulatory standards) have a faster approval process than drugs from other locations.
In recent years ANMAT has introduced several new regulations, including requirements for electronic submissions, updated guidelines for over-the-counter drug labeling, and new rules for registering orphan drugs for rare diseases.
Hypertension remains difficult to treat effectively despite available drugs. Aggressive treatment of moderate and mild hypertension through combinations of drugs from different classes leads to better outcomes. Combination therapy is recommended to control blood pressure as it is more effective than monotherapy due to targeting multiple mechanisms. Fixed-dose combinations have advantages over individual drugs such as better blood pressure control, fewer side effects, and increased compliance.
Steps to Compliance with the European Medical Device RegulationsApril Bright
The document summarizes proposed changes to the European Medical Device Regulations (MDR). It discusses expanding the regulations to cover clinical investigations in Europe and adverse incident reporting. It outlines the classification system for medical devices and conformity assessment procedures. Key aspects include new definitions, unique device identification requirements, essential safety and performance standards, and requirements for economic operators, notified bodies, and identification/traceability of devices. The European database EUDAMED is also mentioned.
The high stakes of running an oncology clinical trialDavid Levin
Unlike other therapeutic trials, oncology trials are more sensitive in nature and require specific clinical expertise to properly manage. Many participants are required to have already undergone front and even second lines of therapy and only if these have failed are they eligible for the experimental and toxic drugs often required in oncology trials. Costs are high, enrollment can be challenging and you are often working with medically-fragile patients. However, when managed properly, effective oncology trials can save lives, generate new revenue streams and make breakthrough discoveries in a challenging therapeutic area.
Clinical Research Organization Services | Contract Research Company - PepgraPEPGRA Healthcare
Pepgra is a global contract research organization and drug development services company. It provides various phases of clinical research trials services to pharmaceutical and biotechnology companies to help reduce the time and costs associated with drug development.
Contact Us:
Website : https://bit.ly/33Fwsye
Email us: sales.cro@pepgra.com
India: +91 9884350006
United Kingdom: +44- 74248 10299
ResearchDevelopment RA SA - Overview - Linkedin 19Aug15Pablo Liuboschitz
This document provides information about Research & Development RA SA, a clinical research organization operating in Latin America. It outlines their mission to provide high-quality clinical trials in the region according to international standards. The management team is described, including the founders Pablo and Santiago Liuboschitz. The company's experience conducting trials in Argentina and expanding to other Latin American countries since 1993 is also summarized. Services offered include clinical monitoring, data management, and logistics support for Phase I-IV trials across therapeutic areas.
Anthony Presentation at DIA Chicago Oct 2008AKTaylor
The requirements of the clinical trial databases provision in the FDA
Amendments Act apply to academic and independent investigators
as well as to industry conducted clinical trials. This session will
highlight the challenges faced by academic and independent investigators
and best practices in registering clinical trials and establishing
procedures for reporting study results to ClinicalTrials.gov.
This document provides information about a biosimilars summit to be held March 30-31, 2011. It summarizes:
1) The summit will focus on leveraging the regulatory, legal and clinical realities of the Biologics Price Competition and Innovation Act to achieve maximum commercial value for follow-on biologics.
2) Attendees can choose from two pre-conference workshops on March 30th focusing on reimbursement landscapes for biosimilars or keys for commercial success in ex-US biosimilar markets.
3) The main conference on March 30-31st will feature panels on navigating patent disputes for biosimilars, FTC perspectives on market competition, and how innovative
1. The healthcare digital landscape is rapidly changing, with growth in new media channels and a fragmentation of how content is produced and consumed.
2. Key trends include a rise in short-form content, user-generated content, and a decline in traditional channel dominance as consumers control their media experiences more.
3. Pharmaceutical companies now have more digital options to consider, including using digital to support traditional activities, replace some traditional activities, and extend their reach to new audiences.
Saudi arabia medical device regulatory processEMERGO
To market medical devices in Saudi Arabia, devices must receive marketing authorization from the Saudi Food and Drug Authority (SFDA). The SFDA application is reviewed for completeness then sent to a third party for technical review, which can involve multiple rounds of questions. Once approved, the SFDA issues a certificate allowing marketing in Saudi Arabia. Appointing an authorized local representative is also required to manage the registration process. Overall, registration times range from 1-6 months but costs and complexity vary depending on the device's risk classification.
ANVISA is the Brazilian Health Surveillance Agency established in 1999 to coordinate the National Sanitary Surveillance System and other health programs. It is responsible for regulating drugs, medical devices, food, cosmetics and other products. ANVISA monitors prices, conducts inspections, and provides technical support. It aims to protect public health through sanitary control of production, marketing and borders. ANVISA is part of the decentralized National System of Sanitary Surveillance and works with various federal, state and municipal agencies.
Chinese Food and Drug Administration (CFDA) Regulatory Approval Process: Medi...NAMSA
The document summarizes China's regulatory approval process for medical devices. It outlines the testing process manufacturers must go through, including writing custom product standards and undergoing variable performance testing at CFDA-designated sites. Recent changes require Class I devices to file documentation rather than register, and Class II and III devices to conduct clinical trials for approval, with some exceptions. IVD registration requirements also changed, with Class I through filing, and Classes II and III requiring registration and trials.
The document summarizes key information about Argentina's economy, healthcare system, and pharmaceutical industry and regulations.
1) Argentina has a $435.6 billion GDP, ranks 27th in the world and 3rd in Latin America. It has an annual growth rate of 8.8%, ranking 12th globally and 1st in Latin America. Services make up 60% of GDP, industry 30%, and agriculture 10%.
2) Healthcare spending is 8.5% of GDP, with 48% covered by social security and 9% by voluntary insurance. The top therapeutic areas are nervous system, cardiovascular, and digestive disorders. 38% have no healthcare coverage.
3) Drug regulation is overseen by the National Administration
This document provides information about ANVISA, the National Health Surveillance Agency of Brazil. Some key points:
- ANVISA is the regulatory body that oversees pharmaceuticals, cosmetics, medical devices and other health products in Brazil. It was established in 1999.
- ANVISA's mission is to protect and promote public health by ensuring safety and quality standards for products and services.
- It is responsible for monitoring drug prices, medical device approval, tobacco control and more. ANVISA works with the Brazilian Ministry of Health.
- Detailed guidelines are provided around the registration of new drugs, generic drugs, medical devices and other regulated products in Brazil according to ANVISA's
Strategies and Opportunities of Outsourcing -Product Development and Manufact...daisyrmuzzio
This document discusses strategies and opportunities for outsourcing pharmaceutical product development and manufacturing services from Latin America. It notes that Latin America has the potential to become a key global outsourcing hub for these activities in the next 5-10 years due to benefits like industry growth, innovation, and capabilities to address local health needs. It highlights several Latin American countries' strengths in areas like clinical research capabilities, manufacturing infrastructure, and a growing biotech industry. It also discusses expectations for the region to close gaps in areas like regulatory environments and intellectual property protections.
The document provides information on regulatory submissions in Japan. It discusses:
- Japan's pharmaceutical market size and aging population trends.
- The Ministry of Health and Pharmaceutical and Medical Devices Agency (PMDA) oversee drug regulation. Applications are submitted to PMDA for approval.
- The Common Technical Document (CTD) format is used for submissions, which organizes information into five modules covering administrative data, summaries, quality, nonclinical studies, and clinical studies.
Changes in device classification under the EU Medical Devices and In Vitro Di...Erik Vollebregt
Presentation at the Q1 Intensive MDR/IVDR Readiness
and Transition Management Workshop about classification changes under the EU Medical Devices and In Vitro Diagnostic Regulation
Strategies for Device Approval in China, India, South Korea and AustraliaApril Bright
This session will describe the orthopaedic device regulatory and registration requirements in Asia Pacific markets. Regulatory steps and strategies will be presented for each of these countries. The discussion will also cover ways to gain regulatory information about competitors already selling in these markets. Attendees will leave the session with an understanding of timelines, costs and complexity for approval.
Europe CE Marking for medical devices under new MDREMERGO
Starting in early 2020, medical devices seeking CE Marking certification in Europe must comply with the new Medical Device Regulation (MDR). This will require appointing personnel responsible for regulatory compliance, classifying the device, appointing an Authorized Representative located in the EU, including labeling with this information, and obtaining a Single Registration Number. Manufacturers must also prepare technical documentation, implement a quality management system, and undergo annual audits by a Notified Body to maintain certification.
Argentina has a population of 40 million people and a growing economy, with GDP of $435.6 billion. The pharmaceutical industry in Argentina generates around $4 billion in revenue per year.
The regulatory authority for drugs in Argentina is ANMAT (National Administration of Drugs, Food and Medical Technology). Drug registration pathways depend on where the drug is manufactured - drugs manufactured in Annex I countries (countries with high regulatory standards) have a faster approval process than drugs from other locations.
In recent years ANMAT has introduced several new regulations, including requirements for electronic submissions, updated guidelines for over-the-counter drug labeling, and new rules for registering orphan drugs for rare diseases.
Hypertension remains difficult to treat effectively despite available drugs. Aggressive treatment of moderate and mild hypertension through combinations of drugs from different classes leads to better outcomes. Combination therapy is recommended to control blood pressure as it is more effective than monotherapy due to targeting multiple mechanisms. Fixed-dose combinations have advantages over individual drugs such as better blood pressure control, fewer side effects, and increased compliance.
Steps to Compliance with the European Medical Device RegulationsApril Bright
The document summarizes proposed changes to the European Medical Device Regulations (MDR). It discusses expanding the regulations to cover clinical investigations in Europe and adverse incident reporting. It outlines the classification system for medical devices and conformity assessment procedures. Key aspects include new definitions, unique device identification requirements, essential safety and performance standards, and requirements for economic operators, notified bodies, and identification/traceability of devices. The European database EUDAMED is also mentioned.
The high stakes of running an oncology clinical trialDavid Levin
Unlike other therapeutic trials, oncology trials are more sensitive in nature and require specific clinical expertise to properly manage. Many participants are required to have already undergone front and even second lines of therapy and only if these have failed are they eligible for the experimental and toxic drugs often required in oncology trials. Costs are high, enrollment can be challenging and you are often working with medically-fragile patients. However, when managed properly, effective oncology trials can save lives, generate new revenue streams and make breakthrough discoveries in a challenging therapeutic area.
Clinical Research Organization Services | Contract Research Company - PepgraPEPGRA Healthcare
Pepgra is a global contract research organization and drug development services company. It provides various phases of clinical research trials services to pharmaceutical and biotechnology companies to help reduce the time and costs associated with drug development.
Contact Us:
Website : https://bit.ly/33Fwsye
Email us: sales.cro@pepgra.com
India: +91 9884350006
United Kingdom: +44- 74248 10299
ResearchDevelopment RA SA - Overview - Linkedin 19Aug15Pablo Liuboschitz
This document provides information about Research & Development RA SA, a clinical research organization operating in Latin America. It outlines their mission to provide high-quality clinical trials in the region according to international standards. The management team is described, including the founders Pablo and Santiago Liuboschitz. The company's experience conducting trials in Argentina and expanding to other Latin American countries since 1993 is also summarized. Services offered include clinical monitoring, data management, and logistics support for Phase I-IV trials across therapeutic areas.
Anthony Presentation at DIA Chicago Oct 2008AKTaylor
The requirements of the clinical trial databases provision in the FDA
Amendments Act apply to academic and independent investigators
as well as to industry conducted clinical trials. This session will
highlight the challenges faced by academic and independent investigators
and best practices in registering clinical trials and establishing
procedures for reporting study results to ClinicalTrials.gov.
This document provides information about a biosimilars summit to be held March 30-31, 2011. It summarizes:
1) The summit will focus on leveraging the regulatory, legal and clinical realities of the Biologics Price Competition and Innovation Act to achieve maximum commercial value for follow-on biologics.
2) Attendees can choose from two pre-conference workshops on March 30th focusing on reimbursement landscapes for biosimilars or keys for commercial success in ex-US biosimilar markets.
3) The main conference on March 30-31st will feature panels on navigating patent disputes for biosimilars, FTC perspectives on market competition, and how innovative
1. The healthcare digital landscape is rapidly changing, with growth in new media channels and a fragmentation of how content is produced and consumed.
2. Key trends include a rise in short-form content, user-generated content, and a decline in traditional channel dominance as consumers control their media experiences more.
3. Pharmaceutical companies now have more digital options to consider, including using digital to support traditional activities, replace some traditional activities, and extend their reach to new audiences.
Activa is a full-service CRO based in Argentina established in 2003 with operations in Chile, Uruguay, and Mexico. It aims to be the leading regional Spanish-speaking CRO in Latin America through local expertise, training, and a quality assurance program. Activa offers clinical research, regulatory, pharmacovigilance, quality assurance, and training services across various therapeutic areas for small and large biotech and pharmaceutical clients.
Efficiently Following the AMP Guidelines with VSClinical and Golden Helix Can...Golden Helix
Interpreting somatic variants for the clinical genetic testing of tumors requires hands-on time of the most skilled clinical lab personnel. Various clinical and genomic sources must be queried, papers and guidelines referenced, and an evaluation of the clinical actionability of the mutation determined by the following the AMP guidelines. Yet, there is tremendous potential for reuse of this time consuming and valuable work!
Earlier this summer we launched our VSClinical AMP Guidelines workflow which integrates a lab-specific knowledgebase that saves every biomarkers interpretation in up to seven different snippets that ar reusable across various genomic and clinical contexts. Furthermore, our cancer workflow is bundled with the Golden Helix CancerKB, our expert-curated interpretations of the most common biomarkers for the most common cancer types, reducing the time to your first precision medicine report.
Follow along as we cover:
The interpretation of clinically actionable biomarkers for targeted molecular therapy and diagnostic/prognostic clinical reports for cancer
The different levels and scopes of re-use of the interpretation for each biomarker
Saving, re-using and updating these interpretations over time by multiple users within a clinical lab with an integrated lab-specific knowledgebase
The built in Golden Helix CancerKB that provides default interpretations for most cancer genes, biomarkers and many clinically actionable Tier I/II drug sensitivity and resistance interpretations.
In the world of genomics shaping precision medicine in oncology, the limiting factor is the time-to-sign-off on fully interpreted molecular profile reports.
Solving the operational challenges of oncology clinical trialsRoberto Lara
This executive briefing explores new strategies for solving your oncology clinical operations challenges. It also features valuable insights into how you can enrich your site selection, speed up your start-up times and maximize patient recruitment opportunities here in North America.
Anthony Presentation DIA Florida Ctd Nov2007AKTaylor
Creating a business process that is accurate, predictable, and capable of
meeting the changing needs for disclosing information about clinical trials
in multiple study registries and results databases is difficult. Companies
need to leverage their current clinical trial process, determine if the disclosure
steps will be centralized or decentralized, determine how much to
leverage technology, and decide whether, and how, to use outside
resources. During this session, we will hear how a large pharma, a small
biopharmaceutical company, and a device company developed their clinical
trial disclosure business process.
The document discusses text mining diverse data from different sources and languages. It describes how text mining can search across structured, semi-structured, and unstructured data as well as extend vocabularies to different domains and languages. Precise information extraction is demonstrated by identifying entities and relations within text. Linking information from multiple documents can generate new hypotheses. Exploiting existing structure and integrating text with structured data provides new knowledge and connections. Terminology development involves discovering synonyms and relationships by analyzing language use across different corpora and languages.
CTT is a clinical research organization that conducts Phase 1-4 clinical trials across many therapeutic areas. It provides value to sponsors through rapid start-up, successful subject recruitment strategies, an experienced team, and rapid data entry. The organization was founded in 2001 and has a 15,000 square foot facility and a network of over 50 physicians that allow it to safely and efficiently advance sponsors' research.
Professional Development: A Gap Between Bench 2 BedsideAjaz Hussain
Ajaz Keynote 10th Annual Dr. Charles I Jarowski Industrial Pharmacy Symposium. St. John’s University, D’Angelo Center Ballroom | Queens, NY 11439 | Monday, June 4, 2018.
Human development, or lack thereof, is reflected at times of challenge and controversy. The mounting challenges and controversies today are a reflection of our current order of consciousness. We will never solve the problems tomorrow with the same order of consciousness we are using to create the problems of today. We must be the change. To do so, we must pay attention to a canary which is tweeting in the coals of our mind. We must agree to see the elephant in the dark. Only by our commitment to hold high our knowledge candles, and to be together strong, we genuinely are suitable and capable of confronting risks lurking in our collective darkness. We are in the dark, our candles held high, no one but us knows how secure or insecure we feel inside. It doesn’t matter as long as we remain committed to illuminating the darkness. In doing so, we raise our order of consciousness!
2nd Annual Proactive GCP Compliance, April 2011, Arlington, VAExL Pharma
The document is an invitation and program for the 2nd annual "Proactive GCP Compliance" conference organized by Exl Pharma. The key details are:
1) The conference will take place from April 4-6, 2011 in Arlington, Virginia and focuses on helping attendees address GCP compliance challenges from a strategic level through sessions led by over 30 experts from major pharmaceutical companies.
2) It provides an opportunity for senior clinical quality and compliance professionals to benchmark their strategies, learn about new FDA and global regulatory requirements, and share experiences.
3) The program includes keynotes from the FDA, panels on industry responses to regulatory changes, and breakout sessions on topics like continuous quality improvement, risk
This document discusses worksite wellness and how upper cervical chiropractors can lead the wellness revolution by implementing wellness programs at worksites. The key points are:
1) Upper cervical chiropractors have an opportunity to reposition themselves and their profession by focusing on worksite wellness programs which can benefit both employers and employees.
2) Implementing wellness programs at worksites is a top priority and pervasive industry that upper cervical chiropractors are well-positioned to capitalize on given their holistic "innate" approach to health.
3) Worksite wellness programs can help address the rising healthcare costs crisis while also increasing employee productivity and happiness through various initiatives like health f
An experienced Clinical Research Associate with over 18 years of experience in the pharmaceutical industry, including sales, account management, managed care, and clinical research monitoring. She has therapeutic area expertise in areas such as neuroscience, endocrinology, vaccines, oncology, renal, rheumatology, dermatology, gastrointestinal, pain and inflammation, and women's and men's health. She is currently working as a Senior Clinical Research Associate at PremierResearch in Atlanta, GA.
Strand SmartLab - Enabling Precision Medicine at community HospitalsHarsha Rajasimha
Strand SmartLab is a complete soup to nuts solution that enables a community hospital to establish precision medicine testing services in-house. This enables the retention of revenues internally rather than loosing them to external third party laboratories. Genomics driven precision medicine for Cancer and other diseases require highly skilled people, lab equipment, processes, regulatory experts, bigdata software, databases and curation, medical geneticists to interpret the results in clinical settings and genetic counselors. Strand SmartLab brings all these to your institution in a pre-packaged solution.
User perspective for somatic variant analysis in VSClinical AMPGolden Helix
Somatic analysis is a complex and precise process that is constantly evolving. As the volume of available data and the accessibility of sequencing technology increase, so too does the value of a versatile, well-vetted, and efficient workflow solution. In this webcast, we will take a deep dive into the current state of our AMP interpretation software and explore various ways to optimize workflows. For anyone from grizzled VarSeq veterans to those seeing our software for the first time and labs of any size, we will provide a practical overview of our somatic analysis capabilities and how those capabilities scale with improving technology.
Throughout this webcast we will be discussing the following:
- Universal principles of somatic workflows, providing baseline recommendations
- Specific tumor-normal and somatic-only use cases
- VSClinical AMP interpretation hub and some variants of interest
- Opportunities for automation and how to decrease time to report for increased throughput
Join us as we show off the versatility and scalability of our AMP interpretation capabilities!
Similar to Clinipace worldwide: Conducting Clinical Trials in Latin America (20)
User perspective for somatic variant analysis in VSClinical AMP
Clinipace worldwide: Conducting Clinical Trials in Latin America
1. Latin America is Fertile
Ground for Clinical Trials:
What Every Sponsor Needs to Know
Click to edit Master title style
Presented by:
Click to edit Master title style
Barb Geiger, BSN, RN
Executive Vice President of Clinical
Operations at Clinipace Worldwide
3. Conducting Trials in Latin America
Investigators
Sites
Patients
Regulatory Environment
Challenges
Click to edit Master title style
Suggestions for Success
Click to edit Master title style
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
4. Investigators
Experience
Country % Increase No. Trials 2005 No. Trials 2009
Argentina 16 97 112
Brazil 58 153 241
Click to edit Master title style
Mexico
• Source: clinicaltrials.gov
49 106 158
Click to edit Master title style
Many investigators are trained and experienced in the conduct of trials
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
5. Investigators
Training
GCP / ICH courses mandated by some countries for investigators, study
coordinators and nurses
Certification may be required by some regulatory authorities for
principal investigators
Click to edit Master title style
Educational forums at various Universities and Foundations
Investigators Meetings
Study Initiation Meetings
International Conferences
Click to edit Master title style
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
6. Investigators
Science
High value placed on science and protocol design
Involve the local experts in protocol and study design
Investigator roundtables a great source of input
Enthusiasm for the research process
Click to edit Master title style
Click to edit Master title style
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
7. Sites
Public versus Private
National health care varies in each country
• Impacts your ability to do trials requiring specified treatment, e.g.
second line oncology trials
Public versus Private institutions:
Click to edit Master title style
• Socioeconomic differences
• Private insurance for some patients
• Differences in Standard of Care
Click to edit Master title style
Availability of new commercial drugs
Treatment naïve patients
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
8. Sites
Locations
Population in Latin America affects site selection
• 538 million people in the region
• Dense population in major cities
• Ethnic diversity (European, Asian, African)
Click to edit Master title style
May have multiple study sites in one large city
Sites may have a religious or ethnic focus that impacts your trial
Considerations for sites outside of the major cities:
Click to edit Master title style
• Shipping samples
• Patient accessibility and transportation
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
9. Patients
Standard of Care
Public – generics, first line treatment will vary
Private – patient will have access to new treatments
Relationship with healthcare provider
Compliance
Click to edit Master title style
Retention
Respect
Click to edit Master title style
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
10. Patients
Family Support
Altruism
Willingness to participate
Click to edit Master title style
Click to edit Master title style
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
11. Patients
Epidemiology
Ethnic and Genetic Predisposition
• Gastric Cancer – Chile and Peru
• Gallbladder Cancer – Peru
• Cervical Cancer and HPV – throughout the region
Click to edit Master title style
Infectious Diseases
• Tropical
• TB, HIV
Click to edit Master title style
• Reverse Seasons
Pneumonia
Influenza
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
12. The Regulatory Environment
Protect the Welfare and Safety of Study Participants
Based on ICH
Local Regulations mirror ICH
Regulations updated (change) regularly
Click to edit Master title style
Click to edit Master title style
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
13. The Regulatory Environment
Timelines
Process
Informed consent
CTAs
Bioequivalence
Click to edit Master title style
Regional Requirements
Click to edit Master title style
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
14. Timelines
Country Set‐Up/ Ethics IEC MOH Import Total
Translation Committee
Argentina 4 weeks 4‐6 weeks 2 weeks 90 business 1‐2 5 ½
(parallel) days weeks months
Brazil 4 weeks 4‐6 weeks 90 days 90 days 2‐3 8 ½
weeks months
Chile Click to edit Master title style
4 weeks 4‐6 weeks NA Notifica‐ 30 4 months
tion only business
days
Mexico 4 weeks 4‐6 weeks NA 45 business 3 weeks
Click to edit Master title style 4 ½
days months
Peru 4 weeks 2‐4 weeks NA 60 days 3 weeks 4 ½
months
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
15. Process
Site Ethics committees
Generally 4‐6 weeks
Verify membership although they follow GCP / ICH
Investigators often members of EC
Cost approximately $600‐$1,000 USD
Click to edit Master title style
Institution specific requirements, especially for Informed Consent will
not be negotiable
CRO does submission to Ethics Committee
Click to edit Master title style
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
16. Process
Independent Ethics Committee
In some countries an IEC will be necessary
Generally 2‐3 weeks
Cost approximately $600 USD
Established to insure patient safety if institution EC not experience,
Click to edit Master title style
now standard to include
Parallel to site EC
Click to edit Master title style
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
17. Process
National EC
Brazil CONEP
Will take 3 months or longer
Often have questions about:
• Protocol – e.g. use of placebo will require justification
Click to edit Master title style
• Consent – Specific wording will be required
• Patient Follow‐Up – provision of product post‐study
Little leeway for change or negotiation
Click to edit Master title style
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
18. Process
Ministry of Health
Dossier requirements will be very specific – CRO should provide
Sponsor with a detailed list of what is required
• Protocol, IB, C of A etc.
Click to edit Master title style
Contact with evaluators will be allowed, generally e‐mail
Evaluators may not always be expert in the field – make sure the
submission is very clear
MOH has varying importance in the process depending upon the
Click to edit Master title style
country
• Argentina – ANMAT is the primary review
• Chile – no MOH approval required other than notification and
issuance of import permit
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
19. Process
Informed Consent
Provide a template and understand it will be changed
Local language and other languages will be required
Country specific requirements as well as site requirements must be
respected
Click to edit Master title style
Will be the most difficult aspect of the approval process
Click to edit Master title style
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
20. Sample Informed Consent Wording
“In the case of research-related side effects or injury, medical care will be
provided by your doctor or you will be referred for appropriate medical care,
without any costs for you. If you are injured or become sick as a direct result
of the proper administration of the investigational drug, xxxxxxx, or of the
study procedures adequately conducted by you, by your study doctor and
Click to edit Master title style
study staff as required in the study plan, the Sponsor will assume the
responsibility to provide entire assistance and compensation to treat such
medical complications and injuries.
You do not waive any of your legal rights for compensation by signing this
Click to edit Master title style
form. An insurance policy was provided to cover any injuries related to
xxxxxxx used in this study.”
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
21. Sample Informed Consent Wording
“After study completion, if you have not been taken off of the study drug
for any reason (your disease progresses or due to a side effect), your
doctor will determine what the best treatment for you will be. If it is
determined that the test medication, xxxxxxx, is the best treatment
compared to the current available treatments in Brazil, the test
medication will be provided by the sponsor to you without any cost.“
Click to edit Master title style
Click to edit Master title style
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
22. Process
Clinical Trial Agreements (CTAs)
Will be required as part of the submission/approval process
• Unlike in US, the EC and MOH sees the site contracts
• Budget / Cost
Don’t assume the cost will be less in Latin America
Click to edit Master title style
» Investigator grant and CRO cost may be less
» Oversight, shipping, travel etc. will be more
Same grant across all sites in country is likely
Click to edit Master title style
Institution language will be required at many sites – others will sign
with no changes
May have a signature by intervening administrator
Negotiations must be done by local representatives (CRO)
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
23. Regional Requirements
Provision of Comparators
No cost requirement
Continued Treatment
Pregnancy
Insurance / Indemnification
Click to edit Master title style
Click to edit Master title style
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
24. Provision of Comparators
All comparator agents used in trial must be supplied, even if SOC
May be supplied locally or reimbursed
Consider use of generics and need for standardization
Ancillary products must also be provided, e.g. pregnancy tests
Pain meds, antihistamines, anti‐emetics must be provided as needed
Click to edit Master title style
Goal is no cost to patient or institution
Click to edit Master title style
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
25. Sample Informed Consent Wording
“Enough quantity of preventive condom and oral hormonal contraceptive
(efficient methods to prevent pregnancy) will be provided at no cost to all
study participants (condom for men and condom plus oral contraceptive
for women with potential to be pregnant), during the whole study,
including the 2 weeks after you complete treatment.”
Click to edit Master title style
Click to edit Master title style
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
26. Continued Treatment
Patient benefit
Protocol design
Investigator discretion
Compassionate use
Commercial availability
Click to edit Master title style
What if development is stopped?
Must be in informed consent
Click to edit Master title style
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
27. Sample Informed Consent Wording
“You may be taken off of the study only after the analysis of the reasons by
the Ethics Committee that approved the study in the hospital/clinic where you
will be treated. This may occur, e.g., whether the study is stopped or your
study doctor decides not treat you with the study drug anymore. However, in
case of a medical emergency, you may be taken off of the study without a
Click to edit Master title style
previous analysis by the Ethics Committee due to the reason of protection to
your health. This decision will be communicated as soon as possible to the
Ethics Committee that approved the study in the hospital/clinic where you will
be treated.“
Click to edit Master title style
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
28. Bioequivalence
Argentina has new BE study regulations which impact drugs that must be
conducted as BE studies
Some BE studies will enroll patients rather than normal healthies – when
this is the case the assigned evaluator will be from the BE team
Normal healthy studies go to a secondary agency within ANMAT, INAME,
Click to edit Master title style
for additional review
A BE study would normally have to be conducted at a BE unit that fulfills
specific criteria
Sites are inspected by ANMAT as part of the protocol approval process
Click to edit Master title style
The protocol itself, must clearly address all the information inherent to PK
samples: handling, storage, shipping, etc. (not just a worksheet or manual)
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
29. Pregnancy
“If you do become pregnant, you will have to discontinue study treatment,
however you will be followed for 30 days after the child is born. You
should inform your study doctor if you had any problems during your
pregnancy or if your baby had any health problems. Beside the follow up,
entire assistance will be assured to you or your partner who becomes
pregnant (in case of male participant in the study) and to the child, if
Click to edit Master title style
applicable, if any of such persons are injured as a direct result of the
proper administration of the investigational drug, xxxxxxx, or of the study
procedures adequately conducted by you, by your study doctor and study
staff as required in the study plan .
Click to edit Master title style
Breastfeeding mothers cannot participate in this study.
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
30. Insurance
Malpractice insurance not common in public setting
Institutional insurance may be the government
Investigators/Institutions may not be able to indemnify sponsors
“Self Insure” language – may not be a set amount
Click to edit Master title style
Click to edit Master title style
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
31. Sample CTA Insurance Wording
“We do hereby warrant that all investigators in our centre have
malpractice insurance for errors and omissions that might arise under this
study.”
Click to edit Master title style
Click to edit Master title style
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
32. Challenges
Language
Local Translations
Informed consent
• Multiple languages
• Local dialects and variations
Click to edit Master title style
• One Spanish consent is not enough
Regional and Cultural Differences
It is not the United States of Latin America
Changing RegulationsClick to edit Master title style
Keeping up can be difficult
Red ink in dossier
Provincial regulations in addition to national
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
33. Suggestions for Success
Planning
Don’t underestimate the start‐up time and plan for more
Consider import‐export and customs fees into your budget
Shipping costs for central labs – can you do locally?
Holidays
Click to edit Master title style
• National
• Bridge
• Summer
Click to edit Master title style
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
34. Suggestions for Success
Review Process
Never submit protocol amendment during review cycle
Dossier package must be complete and error free (or restarts the
clock) – use the requirement list provided by the CRO
Discuss local regulations with your legal team:
Click to edit Master title style
• Informed consent language (belongs to the site, not the sponsor)
• Insurance requirements
• Patient follow‐up
Click to edit Master title style
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
35. Suggestions for Success
Communication
Always better face‐to‐face
Be careful with email – may be misunderstood
Be clear and polite – demands are not acceptable
Pick up the phone
Click to edit Master title style
Speak clearly and without colloquialisms
Click to edit Master title style
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
36. Suggestions for Success
Culture
Local representative to address regional issues
Speaking Spanish is not enough
Site/Country Informed Consent templates must be respected
Don’t insist on sponsor wording
Click to edit Master title style
• It will be rejected
Click to edit Master title style
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
37. Suggestions for Success
Ethical Considerations
Vulnerable Population?
• Perception of study population as poor, illiterate or without access
to healthcare
• Reliance on healthcare provider or family to make decisions
Click to edit Master title style
• Indigenous populations will require community leader consent
• Patient payments not allowed
Click to edit Master title style
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
38. Successful clinical trials rely
on a variety of factors
Investigational Teams
Target Patient Population
Patient Retention and Compliance
Standard of Care
Click to edit Master title style
Click to edit Master title style
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
39. Debunking the Myths
Investigators are highly trained and have clinical research experience and
staff
There WILL be competition for patients and sites for your trial
Some patients will have health insurance
Not all patients will be treatment naïve
Click to edit Master title style
Most facilities are comparable to or better than European and US sites
Language does not have to be a barrier to success
US FDA does accept data from Latin American sites and conducts
inspections in the region
Click to edit Master title style
Plan ahead and you can manage the timelines for a successful outcome
Latin American sites can help make up for start‐up time with a faster
enrollment rate
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com
40. Q&A
Please submit your questions via the chat feature
Barb Geiger, BSN, RN
Executive Vice President of Clinical
Click to edit Master title style
Operations at Clinipace Worldwide
bgeiger@clinipace.com
Click to edit Master title style
www.clinipace.com
RIGHT‐SIZEDTM CLINICAL RESEARCH SERVICES www.clinipace.com