Phase I Clinical Trial Management Services

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)

Project Management Services

• Act as internal company resource to oversee project and pivotal point of contact
• Prepare Project Plan and budget
• Identify external contractors (manufacture/testing, preclinical pharm/tox)
• Provide oversight and management of vendors
• Facilitate information and methods transfer
• Monitor of project resources, tasks and timeline
• Provide project updates and reports when needed

Sourcing of Individual Contractors and Regular Placements 

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

Apogee Clinical can help you to find one or dozens of clinical professionals to work on your next clinical study. Your size is not an issue; although we have worked with some of the world’s biggest Pharmaceutical companies, we also work closely with start-up companies and understand their different needs.  We work with you to find people who fit into your organization’s structure and culture, and participate effectively in large, small or virtual teams.

Please contact us to discuss your needs. We may have just the right person for your company.