Full Service Study Management

Our services include:

Clinical Development

• Design of Clinical Development Plans (CDPs) and clinical strategy
• Clinical Protocol Design

Study Set-up

• Perform Site identification, pre-qualification and Site Qualification Visit (SQV)
• Negotiate Site Budget and prepare site contract/clinical trial agreement
• Collect essential documentation
• Prepare IRB submissions
• Coordinate Investigator Meetings
• Perform Site Initiation Visit (SIV)

Study Documentation

• Write Investigator’s Brochure (IB)
• Write Protocol and Informed Consent Form
• Prepare Case Report Forms (CRFs)
• Create Study Manual
• Assemble Regulatory Binder

Study Management and Monitoring

• Provide Medical Monitor and coordinate safety review
• Study Monitoring
• Clinical Project Management

Re-Monitoring

• Study Re-Monitoring or rescue monitoring

Advisory Boards

• Identification of medical and/or scientific experts for Advisory Board and management of meetings

GCP Compliance

• Perform audits to assess integrity and acceptability of data and investigator sites
• Ensure that GCPs are implemented throughout the clinical trial
• Ensure regulatory, source documentation and record-keeping requirements for clinical trials
• Prepare for FDA site audits
• Ensure that the informed consent process is followed

Data Management

• Write data management plan
• Develop and build clinical database
• Prepare and annotate CRFs
• Provide data entry and validation
• Generate edit check specifications
• Prepare AE and medication encoding
• Generate data queries
• Prepare comprehensive statistical plan
• Generate SAS tables / listings / figures
• Generate statistical report

Medical Writing

• Generate Clinical Study Report (CSR)
• Write clinical sections of IND and NDA/ BLA (ISSs and ISEs)

Individual Contractors and Regular Placements

We pair highly-skilled clinical professionals with pharmaceutical and biotech companies who have regional, in-house contract, or permanent resource needs.

Because we respect your time and resources we don’t use a shotgun approach to presenting candidates. Instead we take a highly targeted approach to finding you the right person for the role.  We put great care into the selection of candidates to ensure that they meet our stringent standards and your project and corporate needs.