Clinical Product Development Consultants and Medical Monitors Our clinical consultants are board certified, qualified in, internal medicine, pediatric disease, infectious diseases, hematology and oncology. They all have considerable industry experience, at least 15+ years. In most cases they have been in VP positions in industry prior to starting consulting careers. They have provided guidance on the clinical and regulatory strategy and provided both review of regulatory submissions as well as interaction with FDA. One of our medical monitors has been the medical director for a Phase 1 Clinical Research Unit. This gives an added perspective for Phase 1 trial design. All have early and late phase clinical trial experience and worked with biologics and small molecule products. Therapeutic areas:
Clinical Project Managers (CPMs) Our core team of CPMs is based in Northern California. We also have CPMs in select regions of the US. A CPM working in concert with a regional study monitor or CRA can readily be located remotely. Our CPMs have been in industry at the CPM level or higher before becoming a contractor.
Act as the pivotal point of contact for project planning and execution and provide direction and management of all clinical trial operational activities Provide a project plan, timeline, study and site budgets.
Field Monitors, CRAs Our field monitors are available regionally throughout the US. They have at least 5 years of monitoring experience and usually considerably more.
Act as the primary contact with the site and provide study procedural guidance and training and triage protocol related enquiries. They ensure that the investigator adheres to the study protocol and all GCP, and FDA regulations. Perform Site Qualification, Site Initiation, Interim and Close Out Monitoring Visits. As part of their site monitoring visit, Field Monitors review the Case Report Forms for each subject, and verify 100% of source data. Review the site regulatory file, Investigator-IRB correspondence, enrollment, eligibility exemptions, Serious Adverse Events and AEs, study drug accountability, and subject discontinuations. Collect essential study documentation and provide these to the Trial Master File. In the case if paper CRFs, CRFs are sent to Data Management. Where CRFs are DataFax or EDC based, they review documents on site and for all types of CRFs, generate data monitoring queries and follow-up on query resolution. They also develop study tracking logs to monitor sites. Assist with preparation of study documentation and assist the CPM with specific project tasks
GCP Auditors Our GCP auditors are based on the West Coast. They have on average over 15 years of industry experience. Their focus is to assess the GCP compliance of a clinical trial to ensure that the integrity and reliability of the trial data is maintained and that the rights and safety of subjects have been protected.
Audit investigator sites and Sponsor documentation and study procedures, to assess the compliance with GCP-ICH guidelines and FDA regulations. Provide pre-FDA site inspections, of clinical investigators, sponsors, CROs, clinical laboratories, core laboratories, and other vendors. Write Standard Operating Procedures. Develop response and corrective action to FDA 483s and Warning Letters.
Data Management Our Data Management affiliates provide all aspects of biostatistical planning, analysis and Data Management for early stage clinical trials. These are two niche companies that have substantive experience and adequate resources to provide a quality statistical and data management service. Their exceptional abilities and specialty services complement our approach to bringing together a select team of experienced and effective individuals.
Provide the statistical section of protocols, comprehensive statistical analysis plans, database set-up and validation, data collection, double-data-entry for paper CRFs, clinical progress tracking, query generation, data cleaning, statistical data analyses and data reporting and generation of Tables Figures and Listings. Support DataFax, EDC CRFs, pharmacokinetic analysis, meta-analysis, generation of integrated summary of safety (ISS), and integrated summary of efficacy (ISE) for NDA/BLA submissions. Represent Sponsor companies at FDA meeting and discuss statistical trial considerations with FDA medical reviewers and statisticians.
Medical Writers Our Medical Writers have substantial biotechnology experience writing, editing, formatting and publishing Clinical Study Reports (CSRs). Their depth of experience extends well beyond the CSRs to preparation of other clinical and regulatory documents such as clinical protocols, investigator brochures, INDs, pre-meeting packages, Integrated Summary of Safety (ISS) and Efficacy (ISE) per CTD format for NDA and BLA submissions. Their therapeutic areas include oncology, immune mediated disease, cardiovascular, ophthalmology, CNS, endocrine and anti-infective areas.
Prioritize medical writing tasks and work effectively with multiple cross-functional team members such as clinical, biostatistical, and regulatory team members to achieve consensus on the key messages, interpretation of the data, and the substance of the CSR. They will also facilitate communication of team members in order to resolve issues
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