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 all the services needed in the course of a clinical trial. This includes all aspects of site selection, clinical monitoring, project monitoring, and clinical data services. We are experienced in the creation and review of protocols, investigator brochures, DMC/DSMB charters, statistical analysis plans, and other documents. We have extensive professional experience in biostatistics, pharmacovigilance, and in regulatory affairs, serving on IRBs and DSMBs, advising NIH on AAHRPP accreditation, as well as experience working with the FDA, both for biostatistical issues and safety issues. We provide support for many therapeutic indications, including oncology, cardiology, vascular access, Parkinson's disease, diabetes, and many others.
Data Management
Digital Infuzion is experienced in all aspects of data management. Our services include:
- Development of databases
- Data entry and cleaning
- Support of all coding dictionaries
- Logic checks
- Queries
- Database testing
- Data review meetings
- Merging of data from different sources, and in different formats
- Providing clean datasets in CDISC format, or any format of your choosing
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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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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, and in approaches to uncover adverse events
that might go undetected
- 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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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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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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