Full-Service CRO Solutions
Offering a full range of support services for clinical trials including Clinical Pharmacology, Project Management, Data Management, Biostatistics/Programming, PK/PD Analysis, Monitoring, Medical Writing and Multi-Site Trials.
90-Bed Phase I Unit
Project Management
Data Management
Biostatistics
Clinical Monitoring
Medical Writing
PK/PD Analysis
Medical Monitoring
Multi-Site Trials
90-Bed Phase I Unit
Project Management
Data Management
Biostatistics
Clinical Monitoring
Medical Writing
PK/PD Analysis
Medical Monitoring
Multi-Site Trials
90-Bed Phase I Unit
Project Management
Data Management
Biostatistics
Clinical Monitoring
Medical Writing
PK/PD Analysis
Medical Monitoring
Multi-Site Trials
90-Bed Phase I Unit
Project 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 also 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.
Data Management
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 eSource/EDC system, 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 biostatisticians offer comprehensive services, including study design consultation, sample size calculations, randomization schema generation and the development of statistical analysis plans (SAP) and TFL Shells. We conduct valid and relevant analyses of PK/PD, safety, and efficacy data. Collaborating closely with our statistical programming team, we guarantee exceptional quality, peer-reviewed, and validated datasets and outputs, including CDISC-compliant SDTMs, ADaMs and eSub packages.
Clinical Monitoring
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.
Medical Writing
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.
Pharmacokinetic/Pharmacodynamic Analysis & Interpretation
Our expert team of pharmacokineticists are integrated throughout a study, from consulting on study design to planning and execution of PK/PD analyses and reporting of results. This standard includes noncompartmental analysis (NCA), with optional PK modeling and simulation services available, to help shape dose selection, clinical study design and drug development strategies. We also offer expedited interim and topline analyses to support dose escalation and other time-sensitive decision-making. Our commitment to quality is paramount, instilling confidence in the results. When it comes to reporting, our experts work collaboratively with the Sponsor’s team, clearly communicating complex clinical pharmacological findings to key decision-makers.
Medical Monitoring
Our Medical Monitor (MM) is responsible for providing medical management for the study, including guiding the project team and clinical sites on medical and safety protocol-related issues. They will work with the project team to identify risks that could impact the safety and reliability of trial results. The MM also reviews Investigator signoff of patient eligibility, laboratory data and other data (ECGs, scales, etc.), assesses Adverse Events, evaluates severity assessment of protocol deviations, reviews Clinical Database Medical Coding, offers guidance and support to the principal investigator with sponsor guidance in an emergency unblinding scenario, and may participate in Safety Review Committee Meetings.
Multi-Site Trials
The Dr. Vince Clinical Research team has significant experience managing multi-site trials for seamless delivery of high-quality data to our sponsors. We maintain a strategic network of investigator sites across a diverse range of therapeutic areas to conduct Phase I-III multi-site studies in patients, special populations and health normal volunteers. 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 high-quality endpoints.