Factory-CRO, a medical device CRO based in the Netherlands, has 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 the 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,” said Dr. Dirk Meijer, CEO of Factory-CRO. “However, these studies often are 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 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 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 advice on a recovery plan. Factory-CRO also 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 Meijer.