Clinical Trials Services and Clinical Operations
Digital Infuzion provides comprehensive consulting and contract services for clinical project management, clinical monitoring, biostatistics, safety, and medical writing. Our main service offerings in these areas are:
Our staff is available for the creation and review of protocols, investigator brochures, DMC/DSMB charters, statistical analysis plans, and other documents. We have extensive professional experience in serving on IRBs and DSMBs, as well as experience working with the FDA, both for biostatistical issues (such as sample size) and safety issues. We provide support for many therapeutic indications, including oncology, cardiology, vascular access, Parkinson's disease, diabetes, and many others.
Professional Experience
Christine Philput, Ph.D., is the Senior Director of Clinical Operations and Biostatistics at Digital Infuzion, and she is our primary point of contact in the area of clinical trials services. Dr. Philput has served in a variety of senior positions in the area of clinical trials, including Research Director of the Naval Hospital in Portsmouth, VA, Director of Biostatistics at PPD Development in Morrisville, NC, and Chief Clinical Officer of Averion Inc. in Framingham, MA.
Clinical Affairs
We have served in a management capacity for many different CROs (clinical research organizations) and companies, providing consulting for the following:
- Recommendations for CROs with superior monitoring capabilities
- Site recruitment and management
- Strategies for quickest possible IRB approval, particularly with local boards with a history of lengthy turnaround
- Evaluation of site coordinators, the key link to quality data
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Biostatistics
We provide biostatistical consultation, programming, and analyses. Software used includes SAS, StatXact, nQuery Advisor, and other cutting-edge products. Services offered include:
- Recommendations for successful strategies with regulatory agencies, including appearances before such agencies
- Statistical analysis plans for clinical trials and Data Monitoring Committees
- Sample size and power calculations
- Development of tables, listings, figures
- Integrated summaries of safety and efficacy
- All statistical needs for regulatory submissions
- Interim analyses, including appropriate consideration of impact on alpha
- Superior personnel to serve as biostatisticians on Data Monitoring Committees
- Assistance with review of proposed analyses or older reports with advice on additional analyses for best presentation of results
- Production of in-text tables in support of clinical study reports
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Medical Writing
We offer a highly-educated and experienced staff that will provide you with top-notch technical writing. Among the services we offer are the following:
- Assistance with developing a style guide, if your company doesn't have one
- Ability to work with any style guide, and to advise you if any disconnects exist between your style guide and applicable regulations, particularly the Common Technical Document guidelines
- Completely current with the 10th edition of the AMA style guide
- Creation of protocols, investigator brochures, clinical study reports, manuscripts, and publications
- Review of protocols, investigator brochures, clinical study reports, manuscripts, and publications when your staff is too busy to complete them themselves
- Integrated study reports
- Regulatory submissions, including NDAs and PMAs
- Production of in-text tables in support of clinical study reports.
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Pharmacovigilance/Safety
With a broad background in biostatistical support for Data Monitoring Committees (DMCs) and Data Safety Monitoring Boards (DSMBs), we provide you with sensible and accurate statistical support for the doctors on your independent boards. Additionally, we provide:
- Real-time assistance to sites and investigators to assure the quick collection of accurate information on serious adverse events for your medical reviewer
- Consultation in developing a safety plan
- Establishment of DMC and DSMB charters
- Administrative support for DMCs and DSMBs
- Cost-effective production of safety narratives
- Evaluation of CRO pharmacovigilance services
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