Phase I Clinical Trial Management Services

Apogee Clinical provides clinical trial development and management, medical monitoring, study monitoring, data management and report writing services to early stage biotechnology companies.  We are experienced with working in a virtual or minimally resourced environment and are available to support your internal team to assist you to achieve your company’s clinical objectives.

The quality of the project team is key to the excellence of your overall project.  We carefully select a small group of skilled resources from our large US wide network of therapeutically-varied and operationally-experienced professionals. 

For early phase biotech companies, timing is often critical for survival, so we bring a sense of urgency to the project.  Apogee Clinical never takes on more projects than we can comfortably handle, to ensure that we are flexible and responsive to your requirements and changing circumstances.  Our management provides ongoing oversight of the team and takes ownership in your project, so we can keep you informed and work with you to proactively manage any issues that arise.

Our alliances with strategic partners enable us to offer a full range of services for early clinical development and clinical trial management.  If you only require individual expert resources, such as a medical monitor or regional CRA for an early phase study we can mix and match resources and provide individual contract resources as needed. We encourage you to contact us to see for yourself the advantages that Apogee Clinical offers, and allow us to put together a proposal for your next Phase I project.

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)