Home News & Events News overview “International Clinical Trial Rescue” Program for Medical Devices

Anne Leijsen

Head of Medical Writing

July 1, 2014

“International Clinical Trial Rescue” Program for Medical Devices

Republished from FierceBiotech, July 21st, 2014

Factory CRO today announced a new early-detection program designed to help medical device companies correct poorly designed clinical trials, effectively saving the study from ultimately being rejected by FDA or European regulators.

“Because medical device clinical trials are not as lengthy or costly as pharmaceutical trials the industry attracts more start-up companies with novel device ideas,” stated Dr. Dirk Meijer, CEO of Factory-CRO. “However, these studies are often poorly designed and managed or based on incorrect assumptions, thereby increasing the chances the study will be rejected by regulatory authorities.”

When study data is rejected by regulators it often puts these smaller companies at significant business risk, sometimes leading to company closure or bankruptcy.

Often times these studies could have been completed successfully with advice and guidance by knowledgeable staff. Fundamental issues such as making faulty business or medical assumptions or overly strict inclusion-exclusion criteria can derail a clinical trial from the start. Poorly written protocols that are not CFR, GCP, or ISO-14155 compliant also set the stage for clinical trial failure.

Factory-CRO, a leading medical device clinical research organization, has developed a rescue assessment program that can be implemented in as little as three weeks. It includes an audit of the collected data, discussions with senior management about study objectives, review of protocols to identify trouble areas related to enrollment, regulatory compliance, and expert advice on a recovery plan. Finally Factory can assist with the implementation of the rescue plan.

“This early-stage diagnosis and re-alignment can literally mean the difference between success and failure of the device study,” said Dr. Meijer.

About the author

Anne Leijsen Head of Medical Writing

At Factory CRO, Anne is leading the medical writing team. Anne's expertise lies with Clinical Evaluations. At the same time, she has a special interest in ongoing changes in the medical device guidelines, directives and regulations in both the United States and Europe.

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