For Life Science Professionals

Cindy Fazzi

Clinical Research: Common Challenges in Sponsor-CRO Relationship
by Cindy Fazzi, Marketing Communications Specialist, MasterControl, Inc.



Nov 28, 2012 | Free Downloads | email | Print

Share This Article





Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

Outsourcing thrives in good times and bad. Life science companies rely on contract research organizations to complement in-house work in times of growth and expansion, but they also rely on CROs to reduce costs in times of financial downturn.

Not only are clinical trials being outsourced, there is a growing trend toward hiring foreign CROs to conduct clinical trials overseas, a practice known as "offshoring." Whether domestic or overseas, it is likely that outsourcing of clinical research will continue to grow.

This is especially true with pharmaceutical companies that sponsor clinical trials. Over the past decade, the annual growth for drug sponsor spending for CRO services has outpaced annual increases in global spending in new drug development, 13.4 percent versus 9.1 percent, according to a 2010 research by the Tufts Center for the Study of Drug Development.

Not only are clinical trials being outsourced, there is a growing trend toward hiring foreign CROs to conduct clinical trials overseas, a practice known as "offshoring." Whether domestic or overseas, it is likely that outsourcing of clinical research will continue to grow. This makes the sponsor-CRO relationship more critical than ever. How can both parties build an effective relationship? How can they turn a transactional relationship into an enduring partnership?

Common Challenges

Let's explore these questions by taking a closer look at some of the common challenges faced by sponsors and CROs:

Poor Communication: Most communication problems between a sponsor and a CRO stem from vaguely defined expectations. Remember: you can't operate based on assumptions. From the get-go, the sponsor must clearly define what it expects from the CRO, including a complete list of study specifications and requirements, corresponding timeframes, as well as GCP regulations that apply to the CRO. Under FDA rules, sponsors can transfer clinical research duties and functions to the CRO, but the sponsor is ultimately responsible for the integrity of the data generated by the clinical research. The ICH E6 GCP Consolidated Guidance (which has been adopted by the FDA and regulatory bodies in the European Union, Australia, Canada, and other countries) has a similar provision on transfer of functions.

On the part of CROs, they must make a commitment based on what they can realistically accomplish. In other words, don't promise anything you can't deliver.

Poor Management by Sponsor: There are sponsors that are so hands-off they entrust almost everything to the CRO and come in only during a time of crisis. Some sponsors are the opposite: they micromanage every step of the way. The key is to strike a balance between these two extremes. Use your quality and service agreements to define your relationship, as well as the approach for managing it. A sponsor can also use regular audits to monitor CRO performance and direct its management approach.

Lack of CRO Transparency: In industry conferences, sponsors have complained about a lack of transparency on the part of CROs. A good example of this is when a CRO hires subcontractors without discussing it with the sponsor. This is a legitimate concern for sponsors because subcontracting blurs the responsibility between the CRO and the subcontractor, a potential problem when it comes to compliance.

Lack of Common Platform: Creating efficiencies is one of the biggest advantages of outsourcing. But when a sponsor and a CRO use disparate tools, efficiency is more difficult to attain. For example, a sponsor may be using an electronic quality system but the CRO may still be using a paper-based process. Even when all parties involved use electronic tools, they may not have the capability to consolidate their different tools into one platform or to connect with each other for collaboration. Simple tasks such as searching for and tracking of SOPs and essential documents, and routing, review and approval of documents can take longer.

Conclusion

Do any of the abovementioned challenges sound familiar? If they are, you have taken the first step in addressing them by looking at them closely and acknowledging them. It is never too late to talk to the other party. After all, you both want the same thing: successful clinical research. You need only to remind each other that your shared success relies greatly on your ability to overcome these challenges and strengthen your partnership.



Cindy Fazzi, a copywriter at MasterControl Inc., writes about the life science industry and other regulated environments. Her two decades of experience as a news reporter, writer, and editor includes working for the Associated Press in Ohio and New York. She has a master's degree in journalism from Ohio State University.


Share This Article





Watch Related Videos


Download Free Resources
Promotional: Brochure: MasterControl Clinical Management Software
White Paper: Clinical CAPA: Embedding Quality into Clinical Research
White Paper: FDA Guidance for Clinical Investigators, Sponsors and IRBs Regarding Adverse Event Reporting in GCP Regulated Environments
White Paper: How Quality and Compliance Can Help Reduce the Cost and Time Involved in Executing Clinical Trials
White Paper: ISO 15189 Standards: For Medical and Clinical Laboratories