Medical Devices Conference

My name is John Lehmann, Director of Business Development for IMARC Research. I have two primary roles with IMARC Research. First, is creating business opportunities for the company. Next, is handling all marketing related activities for the company. Having these dual roles has been helpful in helping driving awareness and building growth as a top Medical Device CRO.
I joined IMARC in 2009 and have a passion for promoting our company’s values, expanding our relationships with sponsors and attracting new accounts. It has been rewarding to see IMARC grow and prosper over time. I am looking forward to attending MDIP and meeting new contacts and learning about their clinical support needs.

Risk Management is key in planning a medical device study. Thinking through the potential pitfalls and then making mitigation plans to help minimize their likelihood is essential in running a well-controlled clinical study. Having a robust site selection process can also help set the study up for success. Ensuring that sites have an established clinical research infrastructure, experienced personnel, an engaged principal investigator, and access to the target patient population will help ensure that study is run in a compliant manner and that study milestones can be achieved.

Helping the sponsor and sites run a well-controlled, compliant clinical study starts with writing a solid protocol. When drafting the protocol, the following “tips” will help decrease the likelihood of non-compliance issues globally:
•  Incorporate human subject protection requirements specific to your clinical trial that meet both FDA and international requirements.
•  Consider what the standard of care is throughout all regions and draft the protocol accordingly. If standard of care is different from region to region, allow flexibility for those differences in the protocol.
•  Avoid mandating requirements for Institutional Review Board (IRB) or Ethics Committee (EC) Reporting, as each IRB/EC may have different requirements. By mandating it in the protocol, it becomes a regulatory requirement with which not all sites can comply.
•  Define in the protocol which requirements the study is being conducted under and train each site accordingly.

Monitoring of clinical studies is a regulatory requirement and is necessary for ensuring that quality data is submitted to regulatory authorities. Auditing, while not a regulatory requirement, provides another layer of oversight that focuses on process-level issues. Auditing can be used throughout the study to identify non-compliance trends and note improvements that could be made in order to improve the overall quality of the clinical study. Auditing done earlier in the process adds more value in that sponsors and sites then have sufficient time to address any identified non-compliances to ensure they don’t recur.
IMARC suggests auditing the trial master file at the following key milestones:
•  After site initiation activities have occurred
•  About halfway through the study
•  In preparation for regulatory inspections
For sites, IMARC suggests auditing them after about 25-50% of their subjects have been enrolled.

IMARC’s robust training program based solidly in US and international regulations situates us to have a positive impact on human subject protection and the overall compliance of a clinical study. In 20 years, none of IMARC’s sites or sponsors have ever received an FDA warning letter. Made up of project management, data management, monitoring, auditing, and others, IMARC’s clinical trial teams work side by side with sponsors to identify potential risks, establish mitigation strategies, implement those strategies, and communicate throughout the process with both sponsors and sites to ensure human subject protection and worldwide acceptance of quality data.

New global post-market requirements for clinical data may prove to be a burden on both sponsors and sites, and could be a big game changer in the next 5-10 years. Coming up with an electronic means of collecting the necessary data without sacrificing the overall quality of the data may be essential in meeting these requirements. CROs may play a bigger role in helping to alleviate the added burden at both the sponsor and site levels.

This will be IMARC’S first year attending MDIP and we are eager to introduce IMARC Research to new companies and contacts.
It’s also important to stay abreast of current topics in clinical research and to network with others who are experiencing similar challenges.