Reliable Performance
 Absolute Accountability

Patient Data/Site Management

ProClinical Research Consultants specialize in clinical study phases I through IIB and phase IV to bring value and validity to the Sponsors’ endeavor.  Our checklist-precision consistent approach to Pre-Study Site Visits (PSSVs) Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs) and Close-out Visits (COVs) yield detailed descriptions of the site’s condition for Sponsor examination.  Our clients are assured of our dedication to resolve all outstanding issues within the expected timelines. Our consultants consistently meet the data locks and interim analysis deadlines.  

ProClinical Research Consultants are proficient professionals.  That means we meet timeline deliverables by working closely with the site and Sponsor to execute site responsibilities and protocol requirements per ICH/GCP Guidelines and FDA regulations.  Our consultants and site managers are learned HIPAA compliers that prioritize patient safety and confidentiality.  The Informed Consent is scrutinized for completion and compliance to ensure the subjects’ understanding and permission to participate in the study have been properly obtained. 

Patient Data/Site Management

Unmatchably skilled with today’s EDC systems and CTMS portals, ProClinical

Research Consultants offer versatile expertise when it comes to timely data entry and query

resolution.  Whether it’s a high-enrolling site or a moderate subject count, our consultants can meet the demands of our clients without compromising the data’s integrity.

Overlooked and careless mistakes often appear at the beginning of a trail.  For ProClinical Research Consultants every (e)CRF is suspect until it is verified to be error-free.

ProClinical Research Consultants interrogate the source documents to confirm that the Case Report Forms (CRFs) are valid, accurate and complete.  Our team of consultants present with an extensive history of audit-readiness.