Clinical Trial Management Services
Hubbell Consulting provides clinical trial management services, all performed under GCPs and in accordance with ICH and the Declaration of Helsinki. These services include:
-
Clinical strategy development
-
Identification, audit, negotiation and selection of clinical sites, CROs, clinical laboratories and third party clinical supplies packaging sites
-
Preparation and submission of IRB/IEC documents
-
Designing CRFs (paper and electronic), diaries, and clinical study forms
-
Performance of site qualification, initiation, monitoring visits, and close out visits
-
Writing study monitoring reports
-
Reviewing clinical data
-
Expediting data clarification and missing data resolution
-
Performance of day to day oversight of the clinical trial
-
Performance of due diligence for technology licensing