Identifying Risks for Outsourced Services
Join our webinar on Tuesday October 4th
8am Pacific : 11am Eastern : 4pm UK : 5pm Central Europe
Regulatory inspectors increasingly scrutinize the selection, qualification and oversight processes of GxP service Providers in clinical research as there are many potential risks to data integrity, data interpretability or patient safety that can arise from insufficient qualification of a service Provider’s capabilities.
The first step to manage the risks associated with outsourcing clinical services is by careful assessment of service Providers’ capabilities, management and adherence to their processes, plus the experience of their team members. Evaluating these categories against a standardized set of criteria that are linked back to industry regulations and best practices is imperative to be able to identify the risks that will carry through into Provider selection and oversight. The qualification process can be very resource-intensive and can increase the lead-time to study start-up.
Furthermore, new and novel trial designs are increasing the number of service Providers in the market such as eClinical technologies which increases operational complexity and potential risk in trials. This webinar will explore how the burden can be lifted and time saved by using the Diligent Qualification Platform to assess service and technology providers against the standards developed by the WCG Avoca Quality Consortium.
Who should attend
This webinar will benefit VPs, Directors and Managers in clinical trial sponsors responsible for:
Quality Assurance
Clinical Operations
Vendor/Outsourcing Management
Compliance/Regulatory Management
Directors/Heads of Innovation
It will also hold useful insights for Contracts, QA and Compliance staff at clinical trial service providers
Hear honest advice and put your questions to our panel of clinical research quality experts
Jennifer Sessions
Senior Director, Diligent Pharma
Jennifer has over 20 years of experience in clinical research, mostly with Eli Lilly and Company. Most recently, she served as the CEO of Cynvec, a private biotech company focused on cancer therapies.
Cristin MacDonald, PhD
Vice President Client Delivery at WCG Avoca
Crissy is the leader of WCG Avoca’s integrated consulting and research solutions and provides consulting services to top pharma, biotech and CROs, overseeing client deliverables, systems and processes.
Crissy has over 12 years of pharmaceutical industry experience with expertise in clinical research, process development and strategic management. Her previous professional roles have touched every stage of the clinical trials process, from pre-clinical research through late-stage clinical development.
Jay Turpen
Head of Client Services with Diligent Pharma
Jay leads a team of staff and Auditors that implement a risk-based qualification service for clients of Diligent Pharma. He has been in the pharmaceutical industry for 32 years and has held various leadership roles. Jay has a wealth of experience in GMP, GLP, and GCP environments with significant real-life experience in developing numerous new drug candidates.
Chris Otto
President and Principal Consultant, CR Otto Consulting
Chris brings almost 30 years of Pharmaceutical industry experience, mainly at Eli Lilly & Co. His experiences include functional leadership roles in Clinical Laboratory Sciences, Clinical Data Sciences, eCOA/ePRO/Connected Devices/Digital Health, Clinical imaging, Decentralized Clinical Trials, Clinical Pharmacology and R&D Information Technology. Over his many years working in Pharma, Chris has sourced work to hundreds of Service Providers from large CROs to small niche technology providers across a broad spectrum of capabilities and geographies.
Put your questions to our expert panel!
Ask our speakers for their comments on any specific questions –
Simply email marketing@diligentpharma.com
Key learning objectives:
1. The need for comprehensive qualification of service and technology providers in clinical research
2. Industry leading standards for research developed by WCG Avoca Quality Consortium
3. The advantages of a standardized approach to provider qualification for consistent and rapid assessment of service providers
4. The support available for sponsors and CROs through the Diligent Qualification Platform, with risk scoring of Request for Information (RFI) answers and shared Vendor Qualification Assessment reports.
5. How to leverage the risks identified in qualification to set your provider oversight plans.
Identifying Risks for Outsourced Services
Join our webinar on Tuesday October 4th