Proficient monitoring and site management experience
that protects, secures and delivers our clients’ products
within specified timeframes are what our nationally
accredited and industry-trained consultants do every day.
Our continuous examination of industry guidance and current regulations allows our consultants to consistently execute per accepted practice and educate the sites and Principal Investigators on industry standards.
Regulatory/IP
At ProClinical Research Consultancy we believe the integrity of the IP is the foundation of the clinical trial. Accuracy, security and stability of the IP are prioritized by our consultants. Our consultants maintain the strictest monitoring safeguards around the IP to ensure that its efficacy is measurable. Routine review of AEs, SAEs, SUSARs and safety reports are conducted to ensure the site has the most current IP related issue information available. ProClinical Research Consultants promote better science by being better monitors. Reliable efficiency is indicative of our verification practice.
Effectively managing regulatory commitments keep a clinical trial on track. Critical document maintenance and IRB notification and verification are mandatory for clinical trial success. ProClinical Research Consultants are highly skilled advance-degreed professionals that ensure our clients Essential Documents, site and IRB correspondence are kept current, accurate and complete throughout the study.
We track and verify all Essential Documents including but not limited to appropriate training for authorized staff, changes in study personnel, required credentials for staff per protocol, IVRS/IWRS confirmations, instrument maintenance, calibrations, IRB notifications, and submissions, membership rosters, protocol amendments, IB tracking, legal and contractual documents, laboratory/vendor certification and IP shipping and receiving documents.
The status of the regulatory files is crucial to the study’s progress. Our consultants are fluent in regulatory maintenance and present with the highest standard of regulatory oversight.
Reliable Performance
Absolute Accountability
ProClinical Research Consultants acutely manage the Investigational Product (IP) with strong discipline and thorough knowledge of the therapeutic and/or device. Liquids, tablets, injectors, patches and topical applications are strictly surveillanced. Blinded and Un-blinded control of IP is precisely maintained. IP delivery, storage, dispensation and return are all meticulously documented for tracking and verification. With targeted emphasis on dosing requirements, our consultants are trained to identify non-compliance, irregular dosing trends and inconsistent/missing dosages immediately. This proactive approach reduces IP discrepancies and protocol deviations.