This document describes pharmacovigilance services offered by Provenance Research, including:
1) Expertise in processing adverse events from clinical trials and post-marketing sources, including case creation, triage, data entry, follow up, and MedDRA coding.
2) Medical review and assessment of cases including causality assessment and signal detection.
3) Regulatory reporting including expedited reports, periodic safety reports, and literature searches.
Pharmacovigilance Smart Sourcing Strategy: Vendor Selection for Safety & Risk...Covance
Strategic planning, sourcing and implementation of safety and risk management operations are complex activities that involve a multitude of factors. Due to the maturity of the outsourcing industry, compliant, quality and efficient safety operations are basic expectations now for the outsourcing of pharmacovigilance (PV) activities. This trend has enabled sponsors to focus their in-house resources on the strategic elements of safety and risk management while leveraging the service provider's capabilities.
Reimagine patient safety 2030 governance through a unified safety platformVeeva Systems
Technology disruptions and healthcare transformation are shifting the roles of QPPV's and senior safety leaders to a more predictive, preventative and participatory safety ecosystem.
During the DIA QPPV Forum, Sharmila Sabaratnam, Senior Director Vault Safety Strategy, shared how you can improve collaboration, benefit-risk data flow and quality and generate insights to maximise patient outcome and minimise avoidable harm through medical governance oversight.
For more information visit:
www.veeva.com/eu/products/vault-safety
Our team of Veeva experts share their forecasts on the top 6 trends that will impact life sciences organizations in 2018. Discover more at bit.ly/VeevaPredicts2018
Reshaping Global ICSR Reporting to Deliver Real-time Visibility and OversightVeeva Systems
Learn how you can reshape global ICSR reporting to deliver real-time visibility and oversight.
In this presentation we discuss:
- Challenges and approaches to safety data management and ICRS reporting
- How technology is making it easier to comply with global and regional requirements
- Considerations for incorporating affiliates into one pharmacovigilance solution
- Strategies for adopting a single multi-lingual safety solution
View the on-demand webinar here: https://bit.ly/35Pfyik
Clinlogix - Improving Pharmacovigilance Outsourcing with Modern Technologies Veeva Systems
Learn how pharma companies and vendors are collaborating and simplifying processes with modern safety solutions. View the on-demand webinar here: https://bit.ly/30eAlJC
Steps to Overcome Information Overload in Clinical ResearchVeeva Systems
See slides from Veeva's Outsourcing Clinical Trials West Coast presentation.
This deck explores the driving forces behind the industrywide move to streamline information exchange in clinical trials. Learn about modern technologies that improve how organizations work together across the clinical environment and discover new approaches to sharing trial information with study partners.
Building a Foundation for Proactive and Predictive PharmacovigilanceVeeva Systems
Learn how PV teams can easily keep up with evolving compliance requirements with modern safety applications that provide better data control and drive greater efficiencies.
View on-demand session: https://bit.ly/3vIzQG9
Pharmacovigilance Smart Sourcing Strategy: Vendor Selection for Safety & Risk...Covance
Strategic planning, sourcing and implementation of safety and risk management operations are complex activities that involve a multitude of factors. Due to the maturity of the outsourcing industry, compliant, quality and efficient safety operations are basic expectations now for the outsourcing of pharmacovigilance (PV) activities. This trend has enabled sponsors to focus their in-house resources on the strategic elements of safety and risk management while leveraging the service provider's capabilities.
Reimagine patient safety 2030 governance through a unified safety platformVeeva Systems
Technology disruptions and healthcare transformation are shifting the roles of QPPV's and senior safety leaders to a more predictive, preventative and participatory safety ecosystem.
During the DIA QPPV Forum, Sharmila Sabaratnam, Senior Director Vault Safety Strategy, shared how you can improve collaboration, benefit-risk data flow and quality and generate insights to maximise patient outcome and minimise avoidable harm through medical governance oversight.
For more information visit:
www.veeva.com/eu/products/vault-safety
Our team of Veeva experts share their forecasts on the top 6 trends that will impact life sciences organizations in 2018. Discover more at bit.ly/VeevaPredicts2018
Reshaping Global ICSR Reporting to Deliver Real-time Visibility and OversightVeeva Systems
Learn how you can reshape global ICSR reporting to deliver real-time visibility and oversight.
In this presentation we discuss:
- Challenges and approaches to safety data management and ICRS reporting
- How technology is making it easier to comply with global and regional requirements
- Considerations for incorporating affiliates into one pharmacovigilance solution
- Strategies for adopting a single multi-lingual safety solution
View the on-demand webinar here: https://bit.ly/35Pfyik
Clinlogix - Improving Pharmacovigilance Outsourcing with Modern Technologies Veeva Systems
Learn how pharma companies and vendors are collaborating and simplifying processes with modern safety solutions. View the on-demand webinar here: https://bit.ly/30eAlJC
Steps to Overcome Information Overload in Clinical ResearchVeeva Systems
See slides from Veeva's Outsourcing Clinical Trials West Coast presentation.
This deck explores the driving forces behind the industrywide move to streamline information exchange in clinical trials. Learn about modern technologies that improve how organizations work together across the clinical environment and discover new approaches to sharing trial information with study partners.
Building a Foundation for Proactive and Predictive PharmacovigilanceVeeva Systems
Learn how PV teams can easily keep up with evolving compliance requirements with modern safety applications that provide better data control and drive greater efficiencies.
View on-demand session: https://bit.ly/3vIzQG9
Managing an end to end Pharmacovigilance system from affiliates to regulatory...MyMeds&Me
MyMeds&Me CEO Dr. Andrew Rut explores how technology can help address the challenges facing Pharmacovigilance teams.
He reviews how the latest intake technology can influence end-user experience and effectiveness, as well as internal value & efficiency.
He concludes that a focus on simplifying case intake re-shapes the traditional PV system, enabling Pharma companies to reap significant process and efficiency benefits.
Speed Clinical Trials from Start to Close: The Path to a Modern CTMSVeeva Systems
Learn how a modern CTMS leads to better oversight, study analytics, and risk identification. This presentation also covers common barriers to the migration process and how to overcome them. Watch a demonstration of Veeva Vault CTMS: http://bit.ly/VaultCTMSDemo
PICI’s Best Practices for Building Oncology Studies in an EDCVeeva Systems
Watch the video here: https://bit.ly/3vrYslR
The Parker Institute for Cancer Immunotherapy (PICI) runs complex clinical trials that depend on an electronic data capture (EDC) system that is adaptive, flexible and innovating at the same pace as their patient-centric mission.
Learn why their legacy EDC system workarounds and custom functions no longer sustained their business, which motivated them to take a new approach. In this webinar, Toby Odenheim, the Director of Technology and Governance, will share how PICI decided to adopt a new EDC system that streamlines the build process for oncology trials and how they better equip their clinical programmers and data managers. PICI’s lead study builder, Gary Smith, will provide a hands-on perspective and share strategies to handle the key challenges that oncology teams face with EDC systems, including:
* Umbrella trials that evaluate multiple therapies
* Adaptive trial branching and routing
* Having an unknown number of treatment cycles
* Amendments and other unplanned changes
Who Will Benefit:
* Data managers
* Database Programmers
* Clinical Programmers
* Clinical programmers in charge of building studies
* Clinical leaders in charge of selecting EDC systems
* EDC Programmers
Meet Your Presenters:
Toby Odenheim
Director, Technology and Governance, Parker Institute for Cancer Immunotherapy
In his current role as director of technology and governance at PICI, Toby Odenheim, MBA, leads an array of technology and process improvement initiatives aimed at accelerating the development of innovative cancer immunotherapy treatments. Core areas of oversight include management of clinical and pharmacovigilance systems, including CTMS, eTMF, IRT, EDC, ePRO, medical coding, safety, and business intelligence systems.
Prior to joining PICI, Odenheim was the founder and principal at Odin Life Sciences Consulting, where he guided companies in the selection, implementation, and validation of best-of-breed clinical technologies. Toby Odenheim has held management positions at Gilead, Synteract, ClinicalSoft, and Pfizer. He holds an undergraduate degree in biology, an MBA, and professional certifications in finance, Oracle database administration, and relational database design.
Gary Smith
Senior EDC Programmer/Analyst, Parker Institute for Cancer Immunotherapy
Gary has over twenty years of experience in clinical programming and is a subject matter expert on study design, configuration, and testing with off-the-shelf EDC systems including Veeva Vault CDMS, Medidata Rave, and Oracle Clinical. Gary has deep expertise in building oncology studies, specifically platform studies, and is currently responsible for all aspects of EDC design and study builds in immuno-oncology studies with the Parker Institute for Cancer Immunotherapy. Gary has developed global libraries for five different companies, spanning medical device and pharmaceutical industries.
Applying Technologies Across the End-to-End Pharmacovigilance Process to Incr...MyMeds&Me
MyMeds&Me CEO Andrew Rut and Oracle Health Science's Director of Safety Analytics, Michael Braun-Boghos review the positive impacts of technology on current pharmacovigilance processes.
AI in Clinical Trials: From Big Sky to Practical ApplicationVeeva Systems
See presentation slides from SCOPE Summit 2020.
Artificial Intelligence (AI) has made its way into the realm of clinical trials and is reshaping how studies are conducted. This presentation looks at the practical ways AI and process automation are being used effectively today to optimize trial design and execution. See this presentation for a look into how technology is revolutionizing the clinical operations landscape – from the smallest biotech to big pharma.
Tufts Research: EDC Trends, Insights, and OpportunitiesVeeva Systems
Watch the video here: https://bit.ly/3yIrVu0
New Tufts research on the eClinical landscape
Learn how seemingly minor decisions in one functional group can significantly impact overall clinical trial timelines. Specifically, those who never release the database before first patient, first visit (FPFV) take more than three weeks longer to lock the database than those who always release before FPFV. Other key findings include:
* Types and volume of data companies manage in EDC
* The biggest causes of database build delays
* How sponsor and CRO cycle times compare for database build, data entry, and database lock
Who Will Benefit:
* Data Management
* eClinical
* Clinical Operations
* Biometrics
* Clinical Development
* R&D IT
Eisai EMEA: Laying the foundation for centralised medical information managem...Veeva Systems
Veeva Vault MedComms Customer Eisai EMEA
Elizabeth Rance, head of EMEA medical information, and David Robertson, EMEA business solutions director from Eisai discussed the following:
-An overview of Eisai’s journey so far to centralize medical information
-The initial feedback from their transformation project and longer-term objectives
-The benefits from instant visibility of metrics
Improve Clinical Trial Processes With a Unified PlatformVeeva Systems
Veeva and Idorsia share how your organization can leverage a unified clinical operating model and drive new levels of efficiency across the entire clinical ecosystem.
Transforming Pharmacovigilance from Operational to Scientifically DrivenVeeva Systems
Learn how scientifically driven pharmacovigilance can enable safety teams to provide faster, more comprehensive benefit-risk assessment to improve patient’s lives. Watch the on-demand webinar: https://go.veeva.com/transforming-pv
Site Connect — The Next Big Step Toward a Collaborative Clinical EcosystemVeeva Systems
Automating information exchange in clinical trials is key to improving how sponsors, CROs, and sites work together. This webinar shares how Veeva Vault Site Connect seamlessly connects sponsor and site operations for better collaboration and faster study execution.
Hear this webinar on-demand: https://go.veeva.com/collaborative-clinical-ecosystem
Tufts Research: Strategies from Data Management Leaders to Speed Clinical TrialsVeeva Systems
Watch the video here: https://bit.ly/3wChmGQ
Learn how top pharmas and CROs plan to speed database build and data collection, as well as their top challenges and future priorities. In this webinar you'll gain insights into:
* Taking an agile approach to database build
* Reducing UAT timelines with a risk-based approach
* Driving innovation at your organization
This in-depth research from Tufts follows their industry-wide eClinical Landscape Study, examining the major cause of database build delays and their impact on trial cycle times.
Meet Your Presenters:
Ken Getz
Director of Sponsored Programs, Tufts CSDD
Richard Young
Vice President, Vault EDC, Veeva Systems
As part of 'Are you seeing 2020', the event held by SFSP-York and the ISA to showcase the IBM Skills truck stopping at York University, Angus Campbell will show us how healthcare is going to change in the next ten years.
A detailed evaluation of the current condition at hospitals helps care providers identify gaps in crucial healthcare functions. They include, patient outreach, triaging, medication management and emergency management.
Using Dynamics 365, care providers can reduce these gaps and this enables them to streamline these healthcare functions better.
At RavenTek, we help healthcare providers secure what matters most, build organizational resilience against cyberattacks and maximize provider Return On Life. We combine world-class technologies, innovative security ideas and a forward-thinking team of problem solvers and consultants to secure healthcare providers. We believe enterprise visibility and persistent, always-on security testing is the essential foundation of every cybersecurity program.
Ryan Coleman is Vice President of Healthcare Cybersecurity at RavenTek.
The Pegwin Insights software platform is used by caregivers at the point of care to measure and monitor a patient’s risk profile and receive early insight into a patient’s deterioration so that timely intervention and preventive action can be taken to avoid post-operative complications. Pegwin Insights is the only evidence-based Machine Learning and AI solution to assist caregivers with better-than-human accuracy in real-time.
Approach to enable your IT systems for FHIR (HL7 standards) complianceShubaS4
This summary deck discusses a practical, step-by-step approach to transform your IT systems for FHIR (HL7 standards) compliance, API-enablement of your legacy for an accelerated go to market using a library of tools and frameworks under the DigitMarket umbrella. It outlines different integration challenges such initiatives encounter and equips you to plan your compliance roadmap for FHIR.
Managing an end to end Pharmacovigilance system from affiliates to regulatory...MyMeds&Me
MyMeds&Me CEO Dr. Andrew Rut explores how technology can help address the challenges facing Pharmacovigilance teams.
He reviews how the latest intake technology can influence end-user experience and effectiveness, as well as internal value & efficiency.
He concludes that a focus on simplifying case intake re-shapes the traditional PV system, enabling Pharma companies to reap significant process and efficiency benefits.
Speed Clinical Trials from Start to Close: The Path to a Modern CTMSVeeva Systems
Learn how a modern CTMS leads to better oversight, study analytics, and risk identification. This presentation also covers common barriers to the migration process and how to overcome them. Watch a demonstration of Veeva Vault CTMS: http://bit.ly/VaultCTMSDemo
PICI’s Best Practices for Building Oncology Studies in an EDCVeeva Systems
Watch the video here: https://bit.ly/3vrYslR
The Parker Institute for Cancer Immunotherapy (PICI) runs complex clinical trials that depend on an electronic data capture (EDC) system that is adaptive, flexible and innovating at the same pace as their patient-centric mission.
Learn why their legacy EDC system workarounds and custom functions no longer sustained their business, which motivated them to take a new approach. In this webinar, Toby Odenheim, the Director of Technology and Governance, will share how PICI decided to adopt a new EDC system that streamlines the build process for oncology trials and how they better equip their clinical programmers and data managers. PICI’s lead study builder, Gary Smith, will provide a hands-on perspective and share strategies to handle the key challenges that oncology teams face with EDC systems, including:
* Umbrella trials that evaluate multiple therapies
* Adaptive trial branching and routing
* Having an unknown number of treatment cycles
* Amendments and other unplanned changes
Who Will Benefit:
* Data managers
* Database Programmers
* Clinical Programmers
* Clinical programmers in charge of building studies
* Clinical leaders in charge of selecting EDC systems
* EDC Programmers
Meet Your Presenters:
Toby Odenheim
Director, Technology and Governance, Parker Institute for Cancer Immunotherapy
In his current role as director of technology and governance at PICI, Toby Odenheim, MBA, leads an array of technology and process improvement initiatives aimed at accelerating the development of innovative cancer immunotherapy treatments. Core areas of oversight include management of clinical and pharmacovigilance systems, including CTMS, eTMF, IRT, EDC, ePRO, medical coding, safety, and business intelligence systems.
Prior to joining PICI, Odenheim was the founder and principal at Odin Life Sciences Consulting, where he guided companies in the selection, implementation, and validation of best-of-breed clinical technologies. Toby Odenheim has held management positions at Gilead, Synteract, ClinicalSoft, and Pfizer. He holds an undergraduate degree in biology, an MBA, and professional certifications in finance, Oracle database administration, and relational database design.
Gary Smith
Senior EDC Programmer/Analyst, Parker Institute for Cancer Immunotherapy
Gary has over twenty years of experience in clinical programming and is a subject matter expert on study design, configuration, and testing with off-the-shelf EDC systems including Veeva Vault CDMS, Medidata Rave, and Oracle Clinical. Gary has deep expertise in building oncology studies, specifically platform studies, and is currently responsible for all aspects of EDC design and study builds in immuno-oncology studies with the Parker Institute for Cancer Immunotherapy. Gary has developed global libraries for five different companies, spanning medical device and pharmaceutical industries.
Applying Technologies Across the End-to-End Pharmacovigilance Process to Incr...MyMeds&Me
MyMeds&Me CEO Andrew Rut and Oracle Health Science's Director of Safety Analytics, Michael Braun-Boghos review the positive impacts of technology on current pharmacovigilance processes.
AI in Clinical Trials: From Big Sky to Practical ApplicationVeeva Systems
See presentation slides from SCOPE Summit 2020.
Artificial Intelligence (AI) has made its way into the realm of clinical trials and is reshaping how studies are conducted. This presentation looks at the practical ways AI and process automation are being used effectively today to optimize trial design and execution. See this presentation for a look into how technology is revolutionizing the clinical operations landscape – from the smallest biotech to big pharma.
Tufts Research: EDC Trends, Insights, and OpportunitiesVeeva Systems
Watch the video here: https://bit.ly/3yIrVu0
New Tufts research on the eClinical landscape
Learn how seemingly minor decisions in one functional group can significantly impact overall clinical trial timelines. Specifically, those who never release the database before first patient, first visit (FPFV) take more than three weeks longer to lock the database than those who always release before FPFV. Other key findings include:
* Types and volume of data companies manage in EDC
* The biggest causes of database build delays
* How sponsor and CRO cycle times compare for database build, data entry, and database lock
Who Will Benefit:
* Data Management
* eClinical
* Clinical Operations
* Biometrics
* Clinical Development
* R&D IT
Eisai EMEA: Laying the foundation for centralised medical information managem...Veeva Systems
Veeva Vault MedComms Customer Eisai EMEA
Elizabeth Rance, head of EMEA medical information, and David Robertson, EMEA business solutions director from Eisai discussed the following:
-An overview of Eisai’s journey so far to centralize medical information
-The initial feedback from their transformation project and longer-term objectives
-The benefits from instant visibility of metrics
Improve Clinical Trial Processes With a Unified PlatformVeeva Systems
Veeva and Idorsia share how your organization can leverage a unified clinical operating model and drive new levels of efficiency across the entire clinical ecosystem.
Transforming Pharmacovigilance from Operational to Scientifically DrivenVeeva Systems
Learn how scientifically driven pharmacovigilance can enable safety teams to provide faster, more comprehensive benefit-risk assessment to improve patient’s lives. Watch the on-demand webinar: https://go.veeva.com/transforming-pv
Site Connect — The Next Big Step Toward a Collaborative Clinical EcosystemVeeva Systems
Automating information exchange in clinical trials is key to improving how sponsors, CROs, and sites work together. This webinar shares how Veeva Vault Site Connect seamlessly connects sponsor and site operations for better collaboration and faster study execution.
Hear this webinar on-demand: https://go.veeva.com/collaborative-clinical-ecosystem
Tufts Research: Strategies from Data Management Leaders to Speed Clinical TrialsVeeva Systems
Watch the video here: https://bit.ly/3wChmGQ
Learn how top pharmas and CROs plan to speed database build and data collection, as well as their top challenges and future priorities. In this webinar you'll gain insights into:
* Taking an agile approach to database build
* Reducing UAT timelines with a risk-based approach
* Driving innovation at your organization
This in-depth research from Tufts follows their industry-wide eClinical Landscape Study, examining the major cause of database build delays and their impact on trial cycle times.
Meet Your Presenters:
Ken Getz
Director of Sponsored Programs, Tufts CSDD
Richard Young
Vice President, Vault EDC, Veeva Systems
As part of 'Are you seeing 2020', the event held by SFSP-York and the ISA to showcase the IBM Skills truck stopping at York University, Angus Campbell will show us how healthcare is going to change in the next ten years.
A detailed evaluation of the current condition at hospitals helps care providers identify gaps in crucial healthcare functions. They include, patient outreach, triaging, medication management and emergency management.
Using Dynamics 365, care providers can reduce these gaps and this enables them to streamline these healthcare functions better.
At RavenTek, we help healthcare providers secure what matters most, build organizational resilience against cyberattacks and maximize provider Return On Life. We combine world-class technologies, innovative security ideas and a forward-thinking team of problem solvers and consultants to secure healthcare providers. We believe enterprise visibility and persistent, always-on security testing is the essential foundation of every cybersecurity program.
Ryan Coleman is Vice President of Healthcare Cybersecurity at RavenTek.
The Pegwin Insights software platform is used by caregivers at the point of care to measure and monitor a patient’s risk profile and receive early insight into a patient’s deterioration so that timely intervention and preventive action can be taken to avoid post-operative complications. Pegwin Insights is the only evidence-based Machine Learning and AI solution to assist caregivers with better-than-human accuracy in real-time.
Approach to enable your IT systems for FHIR (HL7 standards) complianceShubaS4
This summary deck discusses a practical, step-by-step approach to transform your IT systems for FHIR (HL7 standards) compliance, API-enablement of your legacy for an accelerated go to market using a library of tools and frameworks under the DigitMarket umbrella. It outlines different integration challenges such initiatives encounter and equips you to plan your compliance roadmap for FHIR.
Cliniminds- Skill Development Program in PharmacovigilanceCliniminds India
CLINIMINDS brings to you an intensive course covering all the aspects of case processing, specially designed for Pharmacovigilance professional.
Our training program involves:
1. Fresher training for Drug Safety Associate with Hands On experience on safety database
2. Training on Case Processing
3. Training on Aggregate Reporting with Hands On
experience in PSUR/ PBRER writing
4. Training on Signal Detection and Risk Management
5. Training on Regulatory Affairs on Audits
6. Training Medical and Scientific Content Writing
7. Customized Training on Pharmacovigilance (Designed exclusively for Corporate who need domain knowledge on specific area (s) of pharmacovigilance)
Pharmacovigilance Conference on Drug Safety to be held in Jan 2010 at Mumbai, Provenance Research and www.pharmacovigilance.co.in are proud media partners
Ashfield Pharmacovigilance is a global leader in safety and risk management services supporting pharmaceutical, biotech, medical device, consumer health and animal health organizations.
Uniquely focused on pharmacovigilance, we provide outsourced solutions and modified services to augment existing safety departments.
Ashfield Pharmacovigilance has a unique advantage in drug safety and pharmacovigilance due to the high level of expertise across our case managers, project managers, quality and regulatory staff and database administrators. We allow you to focus on your core business, while we partner with you to promote patient safety and product longevity. We achieve this by fostering the open exchange of ideas among organizations throughout the pharmacovigilance community.
By delivering innovative approaches to global case management, aggregate report development, literature search services, signal detection and surveillance, risk management services, safety system implementation, and medical information and call center services, Ashfield Pharmacovigilance is helping to advance the practice of pharmacovigilance on a global scale.
Founded in 2000, we were acquired by UDG Healthcare in 2012 and are proud to be part of its Ashfield division.
Ashfield Pharmacovigilance is headquartered in Research Triangle Park, North Carolina. Learn more about us at www.ashfieldhealthcare.com and follow us on Twitter, @DSA_PV and LinkedIn.
About Ashfield Healthcare
Ashfield Commercial & Medical Services is the sales, marketing and medical arm of UDG Healthcare plc. Established in the UK in 1997, the division is comprised of eight areas of expertise with a history of providing outstanding, client-focused services.
These eight areas of expertise include medical information, pharmacovigilance, healthcare communications, contract sales, market research, leadership training, market access strategy and meeting and event planning. The division consists of more than 5,500 staff in 20 countries.
About UDG Healthcare
Headquartered in Dublin, Ireland, UDG Healthcare plc is a diverse, global healthcare solutions company with interests in healthcare supply chain management, special packaging, sales and marketing and medical services for life science companies.
Find out more http://www.ashfieldhealthcare.com
Computer Software Assurance (CSA): Understanding the FDA’s New Draft GuidanceGreenlight Guru
Understand the FDA's new draft guidance on Computer Software Assurance (CSA).
This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
This training course on Drug Safety and Pharmacovigilance designed to give pharmaceutical and biologic companies operating in the U.S. and EU an understanding of product safety and regulatory compliance.
1. VIGILANCE
Pharmacovigilance Services
PROVENANCE PHARMACOVIGILANCE
SERVICES ADVERSE EVENTS PROCESSING
Provenance Research offers comprehensive Our Pharmacovigilance experts specialize in the
pharmacovigilance services to pharmaceutical, management of both clinical trial and post-marketing
biotechnology and medical device companies across AE’s and offer complete support from case creation
their product’s lifecycle. Our pharmacovigilance to submission. We process cases in either the client’s
team consists of healthcare professionals with database or our database.
wide clinical, as well as drug safety experience
DILIGENCE
spanning multiple therapeutic areas. The dedicated CASE CREATION AND TRIAGE
team of pharmacovigilance associates, scientists,
and physicians are experts in recognizing, • 24/7 call centre support for collecting adverse
processing, analyzing and reporting adverse events. event reports from clinical trials and post-
marketing sources
• Triage of cases based on seriousness and
PROVENANCE ADVANTAGE expectedness
• Expertise that covers both pre and post
marketing pharmacovigilance. CASE PROCESSING
• Comprehensive SOPs, Quality Management • Entry of adverse event data
Systems, and Compliance measures maintain • Active query and follow-up of cases
the pharmacovigilance system audit and • MedDRA coding
COMPLIANCE
inspection ready. • Safety narrative writing and quality check of
case reports for data completeness
• Significant reduction of costs for the client
that can be allocated to their R&D.
MEDICAL REVIEW
• Electronic adverse event reporting
capabilities. • Qualified physician review of the cases for
completeness, accurateness, and capture of all
• Application of good pharmacovigilance medical concepts
practices and integration of new regulatory • Medical assessment/Causality assessment
and technical developments to the system. • Signal detection and Benefit-Risk analysis
SUBMISSIONS
PERFORMANCE
• Adverse events tracking and routing
• Expedited reports submission to regulatory
authorities
• Regulatory reporting to authorities,
investigators, and ethics committees
2. Engagement model
Location
DILIGENCE CORPORATE OFFICE
Provenance Research India Private Ltd.
“JP & Devi Jambukeshwar Arcade,
Provenance provides customized and cost-effective Ground Floor, No 69, Millers Road,
pharmacovigilance solutions based on the requirement Bangalore-560052
of the clients. We adapt our processes to match the Phone: 080-40838809
client’s processes and practices to ensure that quality, email: info@provenanceresearch.in
Our mission timelines, and regulatory requirements are met. www.provenanceresearch.in
“A vigilant today for a safe tomorrow”
Total Pharmacovigilance Solution
Provenance offers complete database services for
PERIODIC REPORTS collecting, analysing and reporting adverse events
supporting multiple studies or products. We utilize
• Annual safety reports a fully validated, ICH E2B and 21 CFR part 11
• IND Annual reports compliant database that has multiple functionalities
• Periodic safety update reports and supports SUSAR’s, ICSR’s, CIOMS I Reports,
• Addendum reports MedWatch Reports, CIOMS Line Listings and
• Bridging reports Tabulated Summaries. We can employ our
• US Periodic reports comprehensive SOPs and engage dedicated resources
to act as the drug safety department of your company.
LITERATURE SEARCH
• Running searches for literature on client Flexible Outsourcing Solution
products from online bibliographic databases
• Entry of identified cases into the safety database Provenance provides flexible outsourcing solutions
• Literature searches for the purpose of inclusion
COMPLIANCE
to clients to meet their regulatory commitments. We
in PSUR, evaluating safety issues and signals. can complement the client’s drug safety department
by providing part pharmacovigilance services, or as
and when needed services to meet their productivity
metrics during periods with spike in volumes. We
TRAINING SERVICES can work in the client’s safety database following
their SOPs and work instructions helping them
• Short-term training programmes in reduce their time and cost significantly. Be it ICSR
Pharmacovigilance processing, Periodic reports, or literature search that
• Certificate course in Pharmacovigilance you require, we can be your trusted safety partner.
VIGILANCE