Find eligible patients that fit your protocol faster, identify and secure proven and/or new sites, forecast and measure progress more efficiency. With Covance's proprietary data, your program hits its mark.
Real-Time Data. Real-World Impact. Info sheet Covance
Data can help, but simply accessing more data only muddies your decision making. With Covance, you get the right analysis on the right data to empower your studies.
Medisafe_What's Next in RWE_mHealth IsraelLevi Shapiro
Presentation by Medisafe CEO, Omri Shor, Oct 19, 2021, for the mHealth Israel community.
- Medisafe’s Patient Engagement Platform
- Real World Evidence: Economic Impact for Pharma
- Connecting Pharma to patients
- Case Study: Supporting Patients through Digital Platform
-
Getting Investigators Onboard: Lab Preferences Make a Difference in Trial Par...Covance
Clinical trials are becoming increasingly complex and competitive, so attracting the best investigator sites to participate in a trial is a crucial step in meeting patient enrollment targets. Learn more about how investigator preference can help meet trial recruitment milestones.
Real-Time Data. Real-World Impact. Info sheet Covance
Data can help, but simply accessing more data only muddies your decision making. With Covance, you get the right analysis on the right data to empower your studies.
Medisafe_What's Next in RWE_mHealth IsraelLevi Shapiro
Presentation by Medisafe CEO, Omri Shor, Oct 19, 2021, for the mHealth Israel community.
- Medisafe’s Patient Engagement Platform
- Real World Evidence: Economic Impact for Pharma
- Connecting Pharma to patients
- Case Study: Supporting Patients through Digital Platform
-
Getting Investigators Onboard: Lab Preferences Make a Difference in Trial Par...Covance
Clinical trials are becoming increasingly complex and competitive, so attracting the best investigator sites to participate in a trial is a crucial step in meeting patient enrollment targets. Learn more about how investigator preference can help meet trial recruitment milestones.
Tomasz Sablinski from Transparency Life Sciences showed at the DayOne Expert event - Next Generation Clinical Trials ways to virtualize clinical trials or parts of them.
Patient Centricity: EHR Pillars to Patient CentricityDayOne
AT the DayOne Experts - Next Generation Clinical Trials, Randy Ramin-Wright from Clinerion demonstrated how patient recruitment works in the digital age.
Next Generation Digital Trials - Introduction to a changing landscape DayOne
Data Analytics Perspective: Stijn Rogiers, SAS and explained why his company is prepared – having being around for decades as the “Rolls Royce” software provider in the fields of data science and analytics.
Paul Coplan, VP, Johnson & Johnson_mHealth IsraelLevi Shapiro
Pesentation, October 19th, 2021: What’s Next in RWE for Medical Devices: The Art of the Possible. Presented by Paul Coplan, ScD, MBA, FISPE, Vice President, Med Device Epidemiology and RWD Sciences, Johnson & Johnson; Adjunct Professor, Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania, Perelman School of Medicine; Fellow of the International Society of Pharmacoepidemiology
- Why RWE is Important for Medical Devices: Challenges with Clinical Trials of Medical Devices (Blinding, Surgeon skill/technique, Hospital process, Product modifications, Long term Follow up, Enrolment challenges)
- Types of Real-World Data Sources (Complaints like MAUDE, Eudramed and Company Databases, Hospital Databases, Electronic Health Records, Claims, Registries, Patient surveys, Surgeon surveys, PROs, Patient Preferences, wearables, sensors, social media, Surgical videos, device generated data, radiographic images)
- FDA CDRH Report on RWE Examples for Regulatory Decisions
- J&J Med Device Epidemiology & Real-World Data Sciences
- US National Evaluation System for Health Technology (NEST)
- RWE for Safety Assessments: Cobalt in Implants and at Work and Risk of Cancer
- Summary of Cobalt Exposure and All-Site Cancer Risk, by Study Type
- Comparative Effectiveness Studies Using RWE
- Summary
a. Use of RWE is important to benefit patients globally and enhance the safety and innovation of medical devices
b. Regulators are interested in using RWE for regulatory decisions but data quality and evidence needs to be regulatory grade
c. NEST has been a useful forum to advance the use of RWE for regulatory decisions in the US
d. RWE can be used for safety assessments, regulatory decisions, comparative effectiveness research, and R&D of products
Data can help, but simply accessing more data only muddies your decision making. With Covance, you get the right analysis on the right data to empower your studies.
Ronan Herlihy on Engaging Clinicians with data on their ordering practicesCirdan
The appropriate ordering project uses data extracted from Electronic Medical Record to create dashboards to inform and engage clinicians in ordering practices. This presentation looks at the techniques used to create answers for the clinicians questions and discusses the purpose behind 12 dashboards. It looks at the change management approaches and challenges.
The initial pilot project has been embraced by a number of local health districts in NSW and templates have been made available along with training tools.
Racing for results: lessons learnt in improving the efficiency of HIV VL and ...SystemOne
In pursuit of the 90–90–90 goals, emphasis has been placed on accelerating centralized laboratory HIV viral load testing of a population that is largely rural and decentralized. Successful
outcome requires effective specimen transport, laboratory testing, and results delivery. This paper focuses on the methods currently employed for results delivery. New innovations in this area are
yielding mixed results; we analyze different approaches and estimate the impact of each on achieving the third ‘90.’
Real-World Data – What’s Next? by Michael Seewald, AstraZeneca for mHealth Is...Levi Shapiro
Presentation by Michael Seewald, Michael Seewald, Ph.D.
Global Head Evidence, AstraZeneca Biopharmaceuticals for mHealth Israel, October 19th, 2021.
Real-World Data is able to uncover local unmet medical need – Call to action to build Learning Healthcare Systems. Significant Variations in Care and Large Potential for Improvement. Real-World Data helps to benchmark efficient use of resources and detect “waste”. Healthcare systems need to address the problem of waste. But fundamental change is hard, and progress slow. Outcomes Transparency Improves ComplianceExample: Swedish myocardial infarction registry. Outcomes Transparency Improves Compliance. Example: Swedish myocardial infarction registry. Improving Outcomes and Creating Value will continue to guide Learning Healthcare Systems- enabled by RWD. Four technological trends as accelerators on our path. Empowered patients- Molecular screening and 24/7 monitoring driving a step change in diagnosis. Algorithmic decision-making: Artificial intelligence supports physician intelligence. Evidence-generating healthcare systemsLive insights on clinical efficacy from digital monitoring. 360° care delivery. Home replaces hospital via digital therapeutics and on-demand remote support. AstraZeneca Areas of Partnering Interest: (https://www.astrazeneca.com/partnering/our-areas-of-partnering-interest.html).
mHealth Israel_Growth Opportunities in Clinical Trial Execution_Craig LipsetLevi Shapiro
Craig Lipsent, former Worldwide Head of Clinical Innovation at Pfizer, presents to the mHealth Israel Community, Feb, 2020. Theme: Clinical trials are vital for developing new medicines but they are broken. Clinical trial trends include the increasing attention and investment in participant & investigator experience
Digitization and innovative data capture. Forecast for clinical trials will be decentralized, distributed, democratized and disruptive.
Find eligible patients that fit your protocol faster, identify and secure proven and/or new sites, forecast and measure progress more efficiency. With Covance's proprietary data, your program hits its mark.
Aldo Rolfo, National Clinical Development Manager, Genesis Cancer Care, Austr...GenesisCareUK
A program that seeks to redefine best practice across the drivers of the GenesisCare business (Quality, Access and Efficiency) in order to deliver on their vision of “Innovating Healthcare. Transforming Lives.”
Getting Right with The Joint Commission's Communication GoalSpok
In pursuit of its mission, The Joint Commission audits and accredits more than 21,000 healthcare organizations and programs for clinical excellence and patient safety. The organization also publishes an annual list of National Patient Safety Goals (NPSG) highlighting specific areas of focus for improvement within the healthcare environment. Improving communications is included in the list as a high priority because communication delays and errors can have serious consequences, for patients as well as hospitals.This webinar explores some of the communication challenges hospitals face and how technology can help them comply with The Joint Commission’s communication goal (NPSG 2).
What's Next in RWE_Amy Rudolph_Novartis_mHealth IsraelLevi Shapiro
Overview of the
- Healthcare ecosystem complexity increasing rapidly
- Pharma industry is facing a crisis: trends shaping the industry
- RWE complements RCTs and captures implementation of innovation
- RWE is one component of the integrated evidence needed for stakeholders
- Integrated Evidence: Optimizing patient access
- Integrated Evidence: Label expansion
- Maximizing the value of data requires a scalable platform and expertise
Primary care-based, teleretinal-screening protocol (Los Angeles Safety Net) UCLA CTSI
UCLA CTSI-Los Angeles County Department of Health Services (DHS) Projects
Principal Investigators: Lauren Daskivich (DHS), Carol Mangione (UCLA)
Diabetic retinopathy (DR) is the leading cause of blindness among working-age Americans, and among Los Angeles Latinos—the ethnic majority of patients in the Los Angeles County (LAC) safety net—the prevalence of DR is ~50%. Despite evidence that early detection and treatment can prevent blindness from DR, a significant number of persons with diabetes in our system fail to receive annual screening examinations and/or sight-saving treatments due to lack of access to specialty care. To date, the effect of a system level intervention on improving access to eye care and definitive treatment for diabetic retinopathy in an urban medically underserved, or safety net, population has not been evaluated. The objective of this project is to evaluate the impact of teleretinal screening on access to specialty ophthalmic care for diabetic patients in LAC who need monitoring or treatment for diabetic retinopathy. We propose a pre-post analysis of the LAC teleretinal screening implementation, and we aim to evaluate the number of patients screened for diabetic retinopathy, the number presenting for timely ophthalmic follow-up care and treatment, and the cost of the program.
Purpose of the Webinar
1.Describe the process of developing an undergraduate MedRec IPE Event involving > 480 senior Medicine, Pharmacy and Nursing students;
2.Explain the logistics of conducting the event in multiple venues and urban/remote locations;
3.Discuss the successes and challenges of communicating MedRec patient safety concepts through this process; and
4.Describe future opportunities for enhancing undergraduate MedRec training in an interprofessional environment.
Watch the webinar recording: http://bit.ly/1fSqsqv
Customized Oncology Development Solutions: Clinical Trials Designed Around You®Covance
Oncology is one of the most research-intensive therapeutic areas, yet no two development programs are the same. No two trials are the same. Each one calls for a customized strategy and distinct trial management approach. Covance develops fit-for-purpose solutions Designed Around You® that enable more efficient clinical trials and focus on what is most valuable to your organization.
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.
Tomasz Sablinski from Transparency Life Sciences showed at the DayOne Expert event - Next Generation Clinical Trials ways to virtualize clinical trials or parts of them.
Patient Centricity: EHR Pillars to Patient CentricityDayOne
AT the DayOne Experts - Next Generation Clinical Trials, Randy Ramin-Wright from Clinerion demonstrated how patient recruitment works in the digital age.
Next Generation Digital Trials - Introduction to a changing landscape DayOne
Data Analytics Perspective: Stijn Rogiers, SAS and explained why his company is prepared – having being around for decades as the “Rolls Royce” software provider in the fields of data science and analytics.
Paul Coplan, VP, Johnson & Johnson_mHealth IsraelLevi Shapiro
Pesentation, October 19th, 2021: What’s Next in RWE for Medical Devices: The Art of the Possible. Presented by Paul Coplan, ScD, MBA, FISPE, Vice President, Med Device Epidemiology and RWD Sciences, Johnson & Johnson; Adjunct Professor, Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania, Perelman School of Medicine; Fellow of the International Society of Pharmacoepidemiology
- Why RWE is Important for Medical Devices: Challenges with Clinical Trials of Medical Devices (Blinding, Surgeon skill/technique, Hospital process, Product modifications, Long term Follow up, Enrolment challenges)
- Types of Real-World Data Sources (Complaints like MAUDE, Eudramed and Company Databases, Hospital Databases, Electronic Health Records, Claims, Registries, Patient surveys, Surgeon surveys, PROs, Patient Preferences, wearables, sensors, social media, Surgical videos, device generated data, radiographic images)
- FDA CDRH Report on RWE Examples for Regulatory Decisions
- J&J Med Device Epidemiology & Real-World Data Sciences
- US National Evaluation System for Health Technology (NEST)
- RWE for Safety Assessments: Cobalt in Implants and at Work and Risk of Cancer
- Summary of Cobalt Exposure and All-Site Cancer Risk, by Study Type
- Comparative Effectiveness Studies Using RWE
- Summary
a. Use of RWE is important to benefit patients globally and enhance the safety and innovation of medical devices
b. Regulators are interested in using RWE for regulatory decisions but data quality and evidence needs to be regulatory grade
c. NEST has been a useful forum to advance the use of RWE for regulatory decisions in the US
d. RWE can be used for safety assessments, regulatory decisions, comparative effectiveness research, and R&D of products
Data can help, but simply accessing more data only muddies your decision making. With Covance, you get the right analysis on the right data to empower your studies.
Ronan Herlihy on Engaging Clinicians with data on their ordering practicesCirdan
The appropriate ordering project uses data extracted from Electronic Medical Record to create dashboards to inform and engage clinicians in ordering practices. This presentation looks at the techniques used to create answers for the clinicians questions and discusses the purpose behind 12 dashboards. It looks at the change management approaches and challenges.
The initial pilot project has been embraced by a number of local health districts in NSW and templates have been made available along with training tools.
Racing for results: lessons learnt in improving the efficiency of HIV VL and ...SystemOne
In pursuit of the 90–90–90 goals, emphasis has been placed on accelerating centralized laboratory HIV viral load testing of a population that is largely rural and decentralized. Successful
outcome requires effective specimen transport, laboratory testing, and results delivery. This paper focuses on the methods currently employed for results delivery. New innovations in this area are
yielding mixed results; we analyze different approaches and estimate the impact of each on achieving the third ‘90.’
Real-World Data – What’s Next? by Michael Seewald, AstraZeneca for mHealth Is...Levi Shapiro
Presentation by Michael Seewald, Michael Seewald, Ph.D.
Global Head Evidence, AstraZeneca Biopharmaceuticals for mHealth Israel, October 19th, 2021.
Real-World Data is able to uncover local unmet medical need – Call to action to build Learning Healthcare Systems. Significant Variations in Care and Large Potential for Improvement. Real-World Data helps to benchmark efficient use of resources and detect “waste”. Healthcare systems need to address the problem of waste. But fundamental change is hard, and progress slow. Outcomes Transparency Improves ComplianceExample: Swedish myocardial infarction registry. Outcomes Transparency Improves Compliance. Example: Swedish myocardial infarction registry. Improving Outcomes and Creating Value will continue to guide Learning Healthcare Systems- enabled by RWD. Four technological trends as accelerators on our path. Empowered patients- Molecular screening and 24/7 monitoring driving a step change in diagnosis. Algorithmic decision-making: Artificial intelligence supports physician intelligence. Evidence-generating healthcare systemsLive insights on clinical efficacy from digital monitoring. 360° care delivery. Home replaces hospital via digital therapeutics and on-demand remote support. AstraZeneca Areas of Partnering Interest: (https://www.astrazeneca.com/partnering/our-areas-of-partnering-interest.html).
mHealth Israel_Growth Opportunities in Clinical Trial Execution_Craig LipsetLevi Shapiro
Craig Lipsent, former Worldwide Head of Clinical Innovation at Pfizer, presents to the mHealth Israel Community, Feb, 2020. Theme: Clinical trials are vital for developing new medicines but they are broken. Clinical trial trends include the increasing attention and investment in participant & investigator experience
Digitization and innovative data capture. Forecast for clinical trials will be decentralized, distributed, democratized and disruptive.
Find eligible patients that fit your protocol faster, identify and secure proven and/or new sites, forecast and measure progress more efficiency. With Covance's proprietary data, your program hits its mark.
Aldo Rolfo, National Clinical Development Manager, Genesis Cancer Care, Austr...GenesisCareUK
A program that seeks to redefine best practice across the drivers of the GenesisCare business (Quality, Access and Efficiency) in order to deliver on their vision of “Innovating Healthcare. Transforming Lives.”
Getting Right with The Joint Commission's Communication GoalSpok
In pursuit of its mission, The Joint Commission audits and accredits more than 21,000 healthcare organizations and programs for clinical excellence and patient safety. The organization also publishes an annual list of National Patient Safety Goals (NPSG) highlighting specific areas of focus for improvement within the healthcare environment. Improving communications is included in the list as a high priority because communication delays and errors can have serious consequences, for patients as well as hospitals.This webinar explores some of the communication challenges hospitals face and how technology can help them comply with The Joint Commission’s communication goal (NPSG 2).
What's Next in RWE_Amy Rudolph_Novartis_mHealth IsraelLevi Shapiro
Overview of the
- Healthcare ecosystem complexity increasing rapidly
- Pharma industry is facing a crisis: trends shaping the industry
- RWE complements RCTs and captures implementation of innovation
- RWE is one component of the integrated evidence needed for stakeholders
- Integrated Evidence: Optimizing patient access
- Integrated Evidence: Label expansion
- Maximizing the value of data requires a scalable platform and expertise
Primary care-based, teleretinal-screening protocol (Los Angeles Safety Net) UCLA CTSI
UCLA CTSI-Los Angeles County Department of Health Services (DHS) Projects
Principal Investigators: Lauren Daskivich (DHS), Carol Mangione (UCLA)
Diabetic retinopathy (DR) is the leading cause of blindness among working-age Americans, and among Los Angeles Latinos—the ethnic majority of patients in the Los Angeles County (LAC) safety net—the prevalence of DR is ~50%. Despite evidence that early detection and treatment can prevent blindness from DR, a significant number of persons with diabetes in our system fail to receive annual screening examinations and/or sight-saving treatments due to lack of access to specialty care. To date, the effect of a system level intervention on improving access to eye care and definitive treatment for diabetic retinopathy in an urban medically underserved, or safety net, population has not been evaluated. The objective of this project is to evaluate the impact of teleretinal screening on access to specialty ophthalmic care for diabetic patients in LAC who need monitoring or treatment for diabetic retinopathy. We propose a pre-post analysis of the LAC teleretinal screening implementation, and we aim to evaluate the number of patients screened for diabetic retinopathy, the number presenting for timely ophthalmic follow-up care and treatment, and the cost of the program.
Purpose of the Webinar
1.Describe the process of developing an undergraduate MedRec IPE Event involving > 480 senior Medicine, Pharmacy and Nursing students;
2.Explain the logistics of conducting the event in multiple venues and urban/remote locations;
3.Discuss the successes and challenges of communicating MedRec patient safety concepts through this process; and
4.Describe future opportunities for enhancing undergraduate MedRec training in an interprofessional environment.
Watch the webinar recording: http://bit.ly/1fSqsqv
Customized Oncology Development Solutions: Clinical Trials Designed Around You®Covance
Oncology is one of the most research-intensive therapeutic areas, yet no two development programs are the same. No two trials are the same. Each one calls for a customized strategy and distinct trial management approach. Covance develops fit-for-purpose solutions Designed Around You® that enable more efficient clinical trials and focus on what is most valuable to your organization.
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.
With almost half of oncology studies failing due to a lack of patient retention, there is a critical need to develop more efficient and patient focused strategies. Jessica Thilaganathan at CRF Health sits down with International Clinical Trials to explain why electronic clinical outcome solutions could be the answer. (Published with permission of International Clinical Trials).
Big data, RWE and AI in Clinical Trials made simpleHadas Jacoby
Technology is slowly but surely penetrating the healthcare industry in general and the clinical trials sector in particular. New and advanced solutions offer a variety of possibilities aimed to both improving existing processes and creating new and more efficient ones. And on top of all stands the desire to make clinical trials more patient centric.
In all of this, even though some of the technologies have yet to mature enough to meet the high quality standards necessary, it is important to know them and begin imagining the promise they hold for clinical trials.
With significant unmet needs for RA patients, it's more important than ever to overcome your Rheumatoid Arthritis development pain points with an experienced and trusted partner.
Build a Path to Success and Accelerate Your NASH Trials Covance
From Phase I-IV, Covance offers operational, medical and regulatory expertise to design trials that meet your unique requirements, proactively mitigate risks, overcome common challenges and efficiently advance your NASH program.
A risk indicator can be any metric used to identify your risk exposure over time. It becomes a KRI when it tracks an important risk, or does so especially well because of its predictive value.
Dr Andrianov, CEO Cyntegrity, discusses the importance of keeping KRIs simple, the link to specific risks, and the emerging common industry KRIs.
A full recording of this webinar is available to MCC members: https://metricschampion.org/
Genomics Solutions - Single Target to Whole Genome AnalysisCovance
With applied Genomics expertise, global co-location with Central Labs and solutions from biomarker discovery to CDx, our genomics solutions will help make your Precision Medicine drug development a reality.
Medical Device and Diagnostics Solutions for Every Stage of Your Product's De...Covance
Getting a medical device to the patient takes more than good technology in today's environment. Compelling evidence and convincing value proposition matter. Competing priorities and differing stakeholder definitions of value are driving the need for creative, connected strategies to get the most from each step in the development process. And - as evidence is gathered - it should be used to inform and iterate regulatory, reimbursement and clinical post-market strategies.
Pharmacovigilance Risk Management for BiosimilarsCovance
This paper focuses on pharmacovigilance (PV) and risk management for biosimilars, the issues and challenges faced in monitoring their safety and possible solutions.
Cell & Gene Therapy post-approval solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
Cell & Gene Therapy enterprise development solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
Cell & Gene Therapy Clinical Development SolutionsCovance
Cell & Gene Therapy clinical development solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
Inhalation Technology - The Future of Effective Respiratory TreatmentsCovance
Nonclinical development channels: technical strategies, formulations and devices. Conventionally, inhaled drugs have been used to deliver medicines targeted at the most widespread respiratory diseases - specifically, chronic obstructive pulmonary disease (COPD) and asthma.
The Challenges Associated with Evaluating the Cost Benefit of Gene Therapies ...Covance
Despite the growing availability of approved gene therapies, decision-makers face significant challenges when evaluating pricing and reimbursement of these novel therapeutics. From determining cost-benefit ratios, setting out patient access criteria and designing reimbursement plans, this white paper explores some of the complex aspects of value assessment for gene therapies, and discusses results from a survey of key decision-makers across Germany, Sweden and the UK responsible for making pricing and reimbursement decisions.
Environmental Risk Assessment for Pharmaceutical DrugsCovance
Understanding the Evaluation and Implications of Findings to the Regulatory Review of Human Medicines in the Environment. Pharmaceutical drugs are intended for the treatment of human disease, therefore the risk of their environmental exposure in clinical use needs to be evaluated. Environmental risk assessment (ERA) is part of the requirements when applying for marketing approval in many geographic regions throughout the world.
Putting the Patient First: Launching a Comprehensive Patient-Centric ProgramCovance
Following a successful sponsor/CRO partnership in which Covance supported a large sponsor's reimbursement call center, a solid partnership had formed, founded on trust and a shared culture. The sponsor expanded this partnership with Covance with the desire to seamlessly transition another reimbursement support program from their current vendor. With the additional successful execution of this project, the sponsor selected Covance as their partner to consolidate all existing hub programs, build a tailored customer relationship management (CRM) tool and develop programs focused on the sponsor's specific needs and enhanced new therapeutic areas and markets.
Top 15 Pharma Gains an Edge in a Highly Competitive Specialty MarketCovance
Due to the complex nature of patient access and reimbursement process for specialty products, the client required a customized hub program to support multiple products, across several therapeutic areas. The unique intricacies of the initiative required a trusted strategic partner who could help advise, inform and support an innovative patient-centric program. In addition to possessing the right expertise and processes, the vendor needed to have a flexible technology platform that could be tailored to support the multiple brand requirements and deliver a seamless experience to various stakeholders including patients, healthcare professionals (HCPs) and specialty pharmacies.
Field Services: Providing On-Site, Field-Based Assistance to Support Customer...Covance
Ensuring access for patients can be complex and impacted by ever-changing factors that require an adaptable and responsive holistic solution to help provider and patients. Relying on a consultative approach, policy expertise and decades of experience, Covance Market Access deploys a variety of different filed-based teams that are tailored to meet your objectives and simplify access for your product.
Overcome the unique challenges of late-phase product development and generate the right data to support your products' objective. Products in late-phase development have complex needs and demands. Programs at this phase support new indications, value communication, adherence strategies, safety and efficacy and more.
Optimizing Each Patient's Product Access ExperienceCovance
Relying on a consultative approach, deep expertise and decades of experience, we work collaboratively with clients to deliver a successful product launch, program transition or program enhancement. Clients benefit from our market insights, strategic and unique approach and ability to continuously refine our processes.
Covance, in partnership with Oracle, offers a full-service, validated, private cloud, single-tenancy solution based on Argus technology, which enables faster and better safety decisions. This automated and integrated solution allows for easy scientific querying and analytics, which improves the quality and efficiency of safety operations. It also enhances compliance with E2B exchange for expedited and periodic reporting, allowing the organization to conduct global case processing, which can scale to tens of thousands of annual cases.
Plant Metabolism Studies: Options for Plant CultivationCovance
Regulators across the world are concerned with ensuring that any residues left in or on a crop after application of a plant protection product (PPP), present minimal risk to the health of humans and animals. To achieve this, regulators need information on the identity of the residues and the levels of residues remaining in or on a crop, in order to assess dietary risk and set maximum residue levels (MRLs). The testing approaches used are harmonized across most countries worldwide, focusing on the Organization for Economic Co-operation and Development (OECD) Test Guidelines (TGs) for pesticide residue chemistry. This e-book paper focuses on the laboratory-based plant cultivation methods that underlie the success of OECD crop metabolism studies, namely TG 501 and 502.
K-REACH - How to Prepare for the K-REACH LegislationCovance
In 2015, South Korea introduced legislation designed to protect human health and the environment from the impact of chemicals. The two pieces of legislation introduced were the: Act on the Registration and Evaluation of Chemicals (K-REACH), which mandates the registration of all new and existing chemicals marketed or imported into South Korea at ≥1 metric ton per year, requiring detailed information on their likely hazard to human health and the environment and the Chemicals Control Act (CCA), which focuses on chemical reporting and chemical accident prevention.
Affordable Stationery Printing Services in Jaipur | Navpack n PrintNavpack & Print
Looking for professional printing services in Jaipur? Navpack n Print offers high-quality and affordable stationery printing for all your business needs. Stand out with custom stationery designs and fast turnaround times. Contact us today for a quote!
3.0 Project 2_ Developing My Brand Identity Kit.pptxtanyjahb
A personal brand exploration presentation summarizes an individual's unique qualities and goals, covering strengths, values, passions, and target audience. It helps individuals understand what makes them stand out, their desired image, and how they aim to achieve it.
Kseniya Leshchenko: Shared development support service model as the way to ma...Lviv Startup Club
Kseniya Leshchenko: Shared development support service model as the way to make small projects with small budgets profitable for the company (UA)
Kyiv PMDay 2024 Summer
Website – www.pmday.org
Youtube – https://www.youtube.com/startuplviv
FB – https://www.facebook.com/pmdayconference
"𝑩𝑬𝑮𝑼𝑵 𝑾𝑰𝑻𝑯 𝑻𝑱 𝑰𝑺 𝑯𝑨𝑳𝑭 𝑫𝑶𝑵𝑬"
𝐓𝐉 𝐂𝐨𝐦𝐬 (𝐓𝐉 𝐂𝐨𝐦𝐦𝐮𝐧𝐢𝐜𝐚𝐭𝐢𝐨𝐧𝐬) is a professional event agency that includes experts in the event-organizing market in Vietnam, Korea, and ASEAN countries. We provide unlimited types of events from Music concerts, Fan meetings, and Culture festivals to Corporate events, Internal company events, Golf tournaments, MICE events, and Exhibitions.
𝐓𝐉 𝐂𝐨𝐦𝐬 provides unlimited package services including such as Event organizing, Event planning, Event production, Manpower, PR marketing, Design 2D/3D, VIP protocols, Interpreter agency, etc.
Sports events - Golf competitions/billiards competitions/company sports events: dynamic and challenging
⭐ 𝐅𝐞𝐚𝐭𝐮𝐫𝐞𝐝 𝐩𝐫𝐨𝐣𝐞𝐜𝐭𝐬:
➢ 2024 BAEKHYUN [Lonsdaleite] IN HO CHI MINH
➢ SUPER JUNIOR-L.S.S. THE SHOW : Th3ee Guys in HO CHI MINH
➢FreenBecky 1st Fan Meeting in Vietnam
➢CHILDREN ART EXHIBITION 2024: BEYOND BARRIERS
➢ WOW K-Music Festival 2023
➢ Winner [CROSS] Tour in HCM
➢ Super Show 9 in HCM with Super Junior
➢ HCMC - Gyeongsangbuk-do Culture and Tourism Festival
➢ Korean Vietnam Partnership - Fair with LG
➢ Korean President visits Samsung Electronics R&D Center
➢ Vietnam Food Expo with Lotte Wellfood
"𝐄𝐯𝐞𝐫𝐲 𝐞𝐯𝐞𝐧𝐭 𝐢𝐬 𝐚 𝐬𝐭𝐨𝐫𝐲, 𝐚 𝐬𝐩𝐞𝐜𝐢𝐚𝐥 𝐣𝐨𝐮𝐫𝐧𝐞𝐲. 𝐖𝐞 𝐚𝐥𝐰𝐚𝐲𝐬 𝐛𝐞𝐥𝐢𝐞𝐯𝐞 𝐭𝐡𝐚𝐭 𝐬𝐡𝐨𝐫𝐭𝐥𝐲 𝐲𝐨𝐮 𝐰𝐢𝐥𝐥 𝐛𝐞 𝐚 𝐩𝐚𝐫𝐭 𝐨𝐟 𝐨𝐮𝐫 𝐬𝐭𝐨𝐫𝐢𝐞𝐬."
Cracking the Workplace Discipline Code Main.pptxWorkforce Group
Cultivating and maintaining discipline within teams is a critical differentiator for successful organisations.
Forward-thinking leaders and business managers understand the impact that discipline has on organisational success. A disciplined workforce operates with clarity, focus, and a shared understanding of expectations, ultimately driving better results, optimising productivity, and facilitating seamless collaboration.
Although discipline is not a one-size-fits-all approach, it can help create a work environment that encourages personal growth and accountability rather than solely relying on punitive measures.
In this deck, you will learn the significance of workplace discipline for organisational success. You’ll also learn
• Four (4) workplace discipline methods you should consider
• The best and most practical approach to implementing workplace discipline.
• Three (3) key tips to maintain a disciplined workplace.
Attending a job Interview for B1 and B2 Englsih learnersErika906060
It is a sample of an interview for a business english class for pre-intermediate and intermediate english students with emphasis on the speking ability.
Enterprise Excellence is Inclusive Excellence.pdfKaiNexus
Enterprise excellence and inclusive excellence are closely linked, and real-world challenges have shown that both are essential to the success of any organization. To achieve enterprise excellence, organizations must focus on improving their operations and processes while creating an inclusive environment that engages everyone. In this interactive session, the facilitator will highlight commonly established business practices and how they limit our ability to engage everyone every day. More importantly, though, participants will likely gain increased awareness of what we can do differently to maximize enterprise excellence through deliberate inclusion.
What is Enterprise Excellence?
Enterprise Excellence is a holistic approach that's aimed at achieving world-class performance across all aspects of the organization.
What might I learn?
A way to engage all in creating Inclusive Excellence. Lessons from the US military and their parallels to the story of Harry Potter. How belt systems and CI teams can destroy inclusive practices. How leadership language invites people to the party. There are three things leaders can do to engage everyone every day: maximizing psychological safety to create environments where folks learn, contribute, and challenge the status quo.
Who might benefit? Anyone and everyone leading folks from the shop floor to top floor.
Dr. William Harvey is a seasoned Operations Leader with extensive experience in chemical processing, manufacturing, and operations management. At Michelman, he currently oversees multiple sites, leading teams in strategic planning and coaching/practicing continuous improvement. William is set to start his eighth year of teaching at the University of Cincinnati where he teaches marketing, finance, and management. William holds various certifications in change management, quality, leadership, operational excellence, team building, and DiSC, among others.
Personal Brand Statement:
As an Army veteran dedicated to lifelong learning, I bring a disciplined, strategic mindset to my pursuits. I am constantly expanding my knowledge to innovate and lead effectively. My journey is driven by a commitment to excellence, and to make a meaningful impact in the world.
Premium MEAN Stack Development Solutions for Modern BusinessesSynapseIndia
Stay ahead of the curve with our premium MEAN Stack Development Solutions. Our expert developers utilize MongoDB, Express.js, AngularJS, and Node.js to create modern and responsive web applications. Trust us for cutting-edge solutions that drive your business growth and success.
Know more: https://www.synapseindia.com/technology/mean-stack-development-company.html
Memorandum Of Association Constitution of Company.pptseri bangash
www.seribangash.com
A Memorandum of Association (MOA) is a legal document that outlines the fundamental principles and objectives upon which a company operates. It serves as the company's charter or constitution and defines the scope of its activities. Here's a detailed note on the MOA:
Contents of Memorandum of Association:
Name Clause: This clause states the name of the company, which should end with words like "Limited" or "Ltd." for a public limited company and "Private Limited" or "Pvt. Ltd." for a private limited company.
https://seribangash.com/article-of-association-is-legal-doc-of-company/
Registered Office Clause: It specifies the location where the company's registered office is situated. This office is where all official communications and notices are sent.
Objective Clause: This clause delineates the main objectives for which the company is formed. It's important to define these objectives clearly, as the company cannot undertake activities beyond those mentioned in this clause.
www.seribangash.com
Liability Clause: It outlines the extent of liability of the company's members. In the case of companies limited by shares, the liability of members is limited to the amount unpaid on their shares. For companies limited by guarantee, members' liability is limited to the amount they undertake to contribute if the company is wound up.
https://seribangash.com/promotors-is-person-conceived-formation-company/
Capital Clause: This clause specifies the authorized capital of the company, i.e., the maximum amount of share capital the company is authorized to issue. It also mentions the division of this capital into shares and their respective nominal value.
Association Clause: It simply states that the subscribers wish to form a company and agree to become members of it, in accordance with the terms of the MOA.
Importance of Memorandum of Association:
Legal Requirement: The MOA is a legal requirement for the formation of a company. It must be filed with the Registrar of Companies during the incorporation process.
Constitutional Document: It serves as the company's constitutional document, defining its scope, powers, and limitations.
Protection of Members: It protects the interests of the company's members by clearly defining the objectives and limiting their liability.
External Communication: It provides clarity to external parties, such as investors, creditors, and regulatory authorities, regarding the company's objectives and powers.
https://seribangash.com/difference-public-and-private-company-law/
Binding Authority: The company and its members are bound by the provisions of the MOA. Any action taken beyond its scope may be considered ultra vires (beyond the powers) of the company and therefore void.
Amendment of MOA:
While the MOA lays down the company's fundamental principles, it is not entirely immutable. It can be amended, but only under specific circumstances and in compliance with legal procedures. Amendments typically require shareholder
2. A DIRECT CONNECTION TO FINDING POTENTIAL
CLINICAL TRIAL PARTICIPANTS
CLIENT CHALLENGE
CLIENT CHALLENGE
REAL-WORLD IMPACT
REAL-WORLD IMPACT
Month 1 Results: 4,829 patients emailed, 523 visited the study website, 7 consented, 6 completed
Patient Service Center (PSC) blood draws
Difficulty recruiting
patients for a virtual
study with a PSC
blood draw
Extremely tight
turnaround times
for launching email
campaigns and
boosting recruitment
PROTOCOL DESIGN TO MAXIMIZE
PATIENT ENROLLMENT OPPORTUNITY
Result: The eligible patient population increased by +50% without compromising the objectives of the trial.
Analyzed LabCorp de-identified
clinical laboratory data to discern
whether small protocol changes
could accelerate recruitment.
Data helped to identify that
making minor changes to the
eGFR cutoff would increase
the patient pool size, therefore
reducing recruitment timelines.
Study to test if a drug
reduced progression of
kidney disease in patients
with Type II diabetes
Study was looking for a
small subset of patients
which represented
<7% of patients
Leveraged LabCorp
database to find potential
patients in key geographies
as specified by the client.
LabCorp sent emails with
study specific website
links to targeted patient
populations.
Seeking patients with
a history of stroke or
cardiovascular event
~150 Million
Lives
>150
million patients
>30
billion test results
>
3. INCORPORATING THE PATIENT VOICE
CLIENT CHALLENGE
CLIENT CHALLENGE REAL-WORLD IMPACT
REAL-WORLD IMPACT
Result: Conducted research with 320 Ulcerative Colitis patients to design a study to meet the client’s
needs. Extended the known investigator database for Ulcerative Colitis with available capacity.
Leveraged Covance Patient
Intelligence Database to
improve patient recruitment
and retention rates.
Identified investigator best-
suited to run Ulcerative
Colitis studies with available
capacity.
Limited patient population
due to competing studies
and the fact that 90% of
patients don’t participate
in clinical trials
Difficulty finding, productive
investigators for study in a
highly competitive space
EXCEEDING RECRUITMENT GOALS FOR A
GLOBAL MULTI-STUDY REGISTRATION PROGRAM
Result: Achieved “first patient in” (FPI) requirement ahead of schedule for all studies in the program.
Beat historical industry performance across a number of key metrics:
18% fewer weeks from final protocol to FPI | 75% more high-performing sites
31% more patients/site/month | 41% fewer non-performing sites
Randomize 2,700
patients within a very
narrow timeframe for
a suite of registration
studies
Get all sites across
the globe up and
running as quickly
as possible
Leveraged Xcellerate®
historical investigator
database to identify and
secure highest performing
investigators in indication.
Based on extensive feasibility
outreach and site capacity
assessment, efficiencies
were identified that allowed
effective overlapping of sites
across the program resulting in
accelerated site start-up and
reduced clinical costs.
90%
~30countries
>20
indications
>175k
unique investigators
>15k
protocols