Offering a full range of support services for Phase I-II clinical trials including Clinical Pharmacology, Project Management, Data Management, Biostatistics/Programming, PK/PD Analysis, Monitoring, Medical Writing and External Site Feasibility and Management.
Our team of highly experienced Project Managers serve as the primary liaison between the Sponsor and the study team. The Project Manager ensures that start-up activities, clinical conduct and key project milestones are delivered on time and as promised. Project Managers are responsible for leading team meetings, developing project plans, maintaining detailed project timelines, managing vendors, developing risk mitigation strategies, managing project-specific training requirements and organizing post-study Lessons Learned meetings.
For all clinical trials, we assign a Lead Data Manager, Coding Specialist and Database Designer. This team develops all relevant documentation, builds and maintains the study database, manages third-party data transfer agreements and performs data reconciliation on external transfers. DVCR’s Data Management team uses a library of C-DISC-certified eCRFs and follows SDTM terminology to build the database. Throughout the project, the team will perform ongoing data review and complete medical coding using WHODrug® and MedDRA® dictionaries.
Biostatistics and Programming
Our team of programmers and statisticians performs a full range of analysis and programming services, including study design consultation, creation of the statistical analysis plan (SAP) and generation of randomization schedules. This also includes the production of tables, listings, and figures, the preparation of interim and exploratory analyses and the creation of C-DISC-compliant SDTM and ADaM datasets.
We believe in maintaining a barrier of separation between our study teams and our CRAs. We only present CRAs qualified by training and experience to Sponsors for consideration and approval. These highly experienced CRAs have extensive training on our SOPs, technology platforms and essential clinical processes to ensure efficient navigation of our systems and effective monitoring of our data collection throughout the clinical trial. In addition, we typically leverage local CRAs to reduce pass-through travel costs significantly. CRAs are readily available to perform blinded and unblinded monitoring activities to meet your project requirements.
DVCR’s highly experienced medical writing team prepares essential study documents, including Protocol Synopses, Informed Consent Forms (ICFs), Protocols and Clinical Study Reports (CSRs). Our Medical Writers are open to using DVCR templates and style guides or sponsor templates. The team’s flexible approach and open communication style ensure the success of your project.
External Site Feasibility and Management
The Dr. Vince Clinical Research team has significant experience managing external site activities for a seamless delivery of high-quality data to our sponsors. We maintain a network of qualified sites across a diverse range of therapeutic areas in order to conduct multi-site clinical programs (Phase I-II). Our robust site feasibility and selection process ensures that the most capable sites are participating in your study and that there is alignment with DVCR’s commitment to speed, customer service and delivering the cleanest data possible.