June 8, 2012

Advanced EDC Trials: Bringing the Team Together

Advanced EDC Trials: Bringing the Team Together

Having screened and selected the outsourced service partners the Sponsor shifts gears to kicking-off the clinical trial. The key challenge typically faced by Biotech/Biopharma drug developers is how to organize these unique ad hoc groups / service providers into working together as a cohesive team. The CDM/STAT group's role as the intermediary with the rest of the team supported by the functionality of a robust EDC system are critical factors for bringing the team together and setting up the clinical study for success.

In this 2nd of 4 webinars, St. Clare Chung and Ann Neale highlight the typical problems associated with the initial stage and presents several tips and solutions to addressing them at the start, while showing how technology can play an integral part in coordination, control and communication.

Topics covered include:

• Typical challenges in organizing a team composed of discreet critical functions
• The eClinical system as a collaboration, communication and collective management tool
• The Data Quality Plan as the new standard that addresses the “missing SOP”
• The role of EDC in promoting data quality
• Maintaining group cohesion, as the clinical trial is underway
• Risk-based site monitoring combined with central data monitoring - an effective cost control tool

What you will learn:

• How to define the workflow process; thereby, getting the team (Project Management, Study Sites, clinical CROs, EDC vendors, CDM/STAT, central labs, etc.) to deliver their best through the eClinical system
• Developing a Data Quality Plan to ensure all parties have defined responsibilities for ensuring data quality
• Achieving the goal of data quality and consistency, while the team is fully informed and operating transparently
• How to ensure that data input meets the desired timelines
• How to oversee site and CRA performance

This webinar is Part 2 of a series on Advanced EDC Trials:

Clinical Operations, Clinical Development, R&D, Clinical Trials Project Managers, Lead CRAs

St. Clare Chung is currently Director of Bio-statistics & CDM at SCiAN Services headquarters located in Toronto, Ontario. She has more than a 20 years of experience in statistical consulting, clinical data management, data analysis and clinical report writing.

Ms. Chung is also one of the original developer's of SCiAN's paper and EDC data management systems and was involved in the concept, design and implementation o f the systems. Her research interests are in Bayesian designs for Phase I/II studies and survival analysis.

Ann Neale is the VP Clinical Operations at Biotie Therapies, Inc. Ms. Neale has over 20 years experience in all phases of clinical development and has managed global clinical programs for biologics and small molecules.

Prior to joining Biotie in 2007, Ms. Neale was VP Clinical at Saegis Pharmaceuticals, Inc. responsible for clinical development of the company's central nervous system (CNS) compounds which were acquired by the Danish neuropharmaceutical company Lundbeck. Other positions have included Sr. Director Development Planning and Operations at Aryx Therapeutics and 10 years as a clinical development consultant. Prior to consulting, Ms. Neale held various positions of increasing responsibility in clinical development at Titan Pharmaceuticals, Applied Immune Sciences (acquired by Rhone- Poulenc Rorer) and Syntex (acquired by Roche).

Ms. Neale received her B.S degree in Nursing from the University of Minnesota in 1985.

SCiAN - a science-technology based contract clinical research company (CRO) - provides e-clinical and EDC solutions and clinical data management systems and services to the healthcare industry for IND stage (phases II - III) clinical trials.