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