From protocol creation through writing the clinical study report, we make sure the clinical program stays on-schedule and in-budget, while maintaining regulatory compliance and quality.
Study sponsors must comply with federal regulations detailing how drugs and devices are shown to be safe and effective, from development through marketing. These regulations can vary by country. We help sponsors make sure they are following the regulations.
This can include writing the study protocol, informed consent, laboratory manuals, and the final clinical study report. It also includes the review and editing of documents. We help manage the writing process and provide medical writing services.
Regulations require that the sponsor of a clinical study has oversight of what happens at the clinical sites. Monitoring is the process by which the sponsor has an agent physically go on-site to verify source data, count drugs, and make sure all the paperwork is being kept properly. We conduct routine monitoring as well as focused site audits to help provide this oversight.
Getting a drug or device to market involves a lot of different activities besides clinical studies in people. Some examples are animal model studies, validating laboratory assays, and preparing regulatory dossiers. Each of these is a project in its own right, and we help make sure these are completed on-time, within-budget, and to the quality level expected.
Through the Trial Master File, the conduct of the study can be re-created. This means there is a lot of paperwork to show how the study was conducted, that staff were qualified and trained, and that proper oversight was maintained. We make sure all of that paperwork has been filed and is accessible.
Clinical studies generate a lot of data. The data sets have to be reviewed to make sure everything is correct. Data also have to be standardized, or cleaned, to make sure everything is consistent. Data management includes these reviews and the process of querying study sites to clarify or correct data. We take care of the reviews and query management, providing reports to the sponsor to help identify and manage risks.
Includes preparation of recruiting materials (advertisements), questionnaires, study binders and manuals, and other physical assets used in the study conduct.
Advertising is often used in clinical studies to help bring in subjects. We create and print flyers, postcards, posters, and other recruiting materials. We also create and use phone screening scripts to call potential subjects for initial qualification.
Study sites typically conduct several studies at the same time. This means they need support from the sponsor for training and day-to-day study conduct. We create and distribute these materials to the study sites to help ensure everything runs smoothly.
Many companies rely on information technology solutions to their problems. Instead of collecting data on paper, they may use a web-based data collection system. Instead of paper files, they may use a cloud-based document management system. We help make sure these systems are set up and work correctly.
Electronic Data Capture systems are used to collect data from the clinical study, either by direct input by study staff or importing from other systems. The validation process makes sure the system does what it is supposed to. This includes documentation, change control, and testing. We provide design and validation services.