Enhanced Your Next Clinical Studies
The CRO Group offers a robust suite of Clinical Trial Services to support the needs of medical device developers as well as other trial sponsors from premarket submissions to post-marketing advertising campaigns, and virtually everything in-between.
All of our Clinical Trial Services comply with Internationally Harmonised Good Clinical Practices (ICH-GCPs) required by FDA under 21 CFR 812, the European Directives and recognised if not required for approval in virtually all corners of the Globe.
Our Clinical Trial Service menu starts with study designs resulting in plans and protocols with endpoints, methodology, and statistical considerations that fit your budget and business goals.
The CRO Group is often able to leverage its Boston area location with its world renowned 7 Dental and Medical Schools, 26 Teaching Hospitals, as well as dozens of nursing, assisted living, and rehab facilities and divergent universities, marketplaces and workplaces to assist in site and principal investigator (PI) selection as well as in patient recruiting and enrollment.
The CRO Group specialises in these services for OTC (Over the Counter) Clinical Studies including Label Comprehension, Usability, and Safety/Efficacy, and has successfully ran and supported our clients running these studies for OTC Aesthetic (Hair Regrowth, Hair Reduction, Temporary Fat Reduction), Mouthguards and other Obstructive Sleep Apnea (OSA) Products, as well as Web App and Mobile App Health software requiring 510(k) clearance.
Our Monitoring and Audit Services conform to FDA, European, as well as International regulations, standards, and guidance. Our seasoned auditors not only interview the CRAs and assess the data for compliance, but feedback essential technical and practical information to the client about the conduct of the trial and issues along the registration pathway. Monitoring, and independent auditing ensures consistently reliable and usable data to support submissions for registration, advertising claims, and or acquisition of government reimbursement. Our monitors work according to CRO Group standard operating procedures or the client’s procedures.
The CRO Group can also assist with completing EU Clinical Evaluations and Post Market Clinical Studies, which many Notified Bodies are now requiring to maintain CE Mark.