Data Monitoring Committees: Simple Solutions for Critical Issues

The use of Data Monitoring Committees (DMCs) is becoming increasingly common in drug development and while they have clear benefits, poor set up and ill-defined communication pathways can cause irreversible problems for a drug development program.

This webinar will focus on two important aspects of Data Monitoring Committees:

1. Data Monitoring Committee Set-Up

• DMC set-up can often be a secondary consideration given the environment of compressed timeframes and emphasis on regulatory approvals and site activation. But because of the importance of the DMC and its potential impact on a study, it is essential that the appropriate DMC members (voting and non-voting) are identified and the operating procedures are discussed and agreed upon during the startup phase of a study.
• With DMCs typically unblinded during ongoing study conduct, most of the documentation for DMCs is highly confidential and sensitive. Therefore it is critical that the necessary ‘firewalls’ be in place and all access to unblinded (closed) documentation be well controlled and easily auditable. In addition, all other DMC content should be managed in a secure, controlled manner.

2. Data Monitoring Committee Communication

• The highly confidential nature of DMC reports and decisions requires a communication solution that is highly secure and enables different levels of access based on specific roles.
• In order to be easily adopted and fully utilized, a DMC communication solution must comply with industry regulations, but also user-friendly, simple to use and able to handle large files.

Learning objectives of the webinar

• DMC members will learn about approaches and solutions that will ensure an effective DMC set-up as well as an easy-to-use method for data exchange and documentation.
• Sponsors or staff at Data Analysis Centers will learn about approaches and solutions that will facilitate the timely set up of DMCs and provide assurances of the secure and controlled dissemination of, and access to DMC documentation.

Speakers

Angela McPartlane, Associate Director of the DMC Unit, PRA Health Sciences

Angela McPartlane has more than 17 years of clinical research experience; including seven years in the Pharmaceutical Industry and over 10 years in the CRO industry. As the leader of the DMC unit she manages a global team of resources who are fully dedicated to DMC support and management. Over the past 5 years PRA Health Sciences has supported the planning and management of DMCs for over 80 projects, covering all phases of drug development and in multiple therapeutic areas.

PRA Health Sciences delivers innovative drug development solutions that improve patients’ lives. Our people love what they do, working tirelessly for clients across all phases and therapeutic areas. With 11,000+ employees covering 80+ countries, we provide an impressive global presence and in-depth knowledge of local regulations, standards of care and cultural customs.

Message Presenter

Andrew Mitchell, Director, Life Sciences Strategy and Product Marketing, Intralinks

Andrew Mitchell has many years of experience working in and with the Life Sciences industry, delivering innovative software solutions. In addition to Intralinks, Andrew’s career includes positions with Covance, Relsys, Medidata and BioPharm Systems (an Oracle Gold implementation partner). With a focus on Software as a Service, Andrew brings his deep subject matter expertise to bear to ensure the delivery of real benefits and enhanced compliance, anchored by a strong belief in providing solutions that simplify and improve the user experience.

Intralinks provides a highly secure platform that helps Pharmaceutical, biotech, medical device companies and clinical research organizations (CROs) to streamline complex and time-sensitive processes such as eISF/eTMF integration, SUSAR report distribution and study start-up with a complete audit trail. Intralinks´ clients automate distribution and collection of sensitive information, centrally organize content while easily managing and monitoring access – making it easier to provide the right information to Investigators, Institutional Review Boards (IRBs)/Ethics Committees ( ECs), regulatory agencies and patients.

Message Presenter