Sponsors and CROs both have key role in quality; FDA

By Nick Taylor

- Last updated on GMT

Related tags: Contract research organization

The FDA is emphasising the key role both sponsors and CROs play in ensuring high quality clinical trials.

Outsourcing of clinical trials presents the US Food and Drug Administration (FDA) and companies with new issues around quality and responsibilities. By properly transferring responsibilities to contract research organisations (CRO) sponsors can eliminate some potential problems.

A sponsor has to indicate what specific responsibilities they’re transferring to the CRO in writing. Anything that’s not specifically described in writing is deemed to be retained by the sponsor​”, Ann Meeker O’Connell, acting associate director at the FDA, told Outsourcing-Pharma.

Sponsors encounter problems when there is “a lack of clarity in the transfer of obligations​”. Other problems can arise when a sponsor only provides limited real-time oversight in managing the CRO.

Meeker O’Connell goes on to list four areas sponsors must address to ensure a smooth transfer of responsibilities to a CRO. While this is important, sponsors must remember they “retain the ultimate responsibility for the quality and integrity of any data…that are submitted to the FDA​”.

Related news

Show more

Related products

show more

Vaccine Innovation in the Era of COVID19

Vaccine Innovation in the Era of COVID19

Covance Patient Safety | 01-Oct-2020 | Sponsored Link

During this time of worldwide crisis, there is an increasing demand for the acceleration of a vaccination for COVID19. Regardless of the great recent advancements...

What to consider when working with CRFs

What to consider when working with CRFs

Formedix | 21-Sep-2020 | Technical / White Paper

For a study to be successful, data collected must be correct and complete. To be correct and complete, forms must be well planned with meticulous attention...

Covance Touchless Drug and Device Vigilance Vision

Covance Touchless Drug and Device Vigilance Vision

Covance Patient Safety | 01-Sep-2020 | Data Sheet

Automation tools enable organizations to identify patterns in structured and unstructured data and facilitate automation of the entire product vigilance...

Lessons Learned: Clinical Trials During a Pandemic

Lessons Learned: Clinical Trials During a Pandemic

PCM TRIALS | 01-Sep-2020 | Technical / White Paper

In a recent survey of clinical trial professionals (including pharmaceutical sponsors, CROs, site representatives and vendors), respondents reported that...

Related suppliers

Follow us

Products

View more

Webinars