BioTech
BioTech Overview
Prevail has had multiple products attain FDA approval and was audited for compliance with all regulations and GCP including 21 CFR Part 11 under the CDER group of the FDA in 2014 with no findings, 483s or warning letters.
The BioTech industry has adopted Prevail’s solution in hundreds of clinical trials and these technologies have been applied in all types of therapeutic areas and with all types of indications. Whether your company has a small molecule, or a biopharmaceutical like a vaccine, cell therapy or gene therapy, the technologies have the flexibility to address the specific complexities of each area and product type. The Single Interface and its modules have successfully been involved in studies with high volume of data for each patient (oncology), complex trial supplies logistics (autologous stem-cells) and data requiring careful consistency across sites (CNS rating scales) and quality review (data from first-time sites and risky geographies).
Prevail has had multiple products attain FDA approval and was audited for compliance with all regulations and GCP including 21 CFR Part 11 under the CDER group of the FDA in 2014 with no findings, 483s or warning letters.
While the technologies are therapeutic area agnostic, they have been applied in the following areas:
Allergy / Immunology, Auto-Immune, Bio-defense, Cardiovascular, Dermatology, Endocrinology, Gastroenterology, Hematology, HIV/Infectious Diseases, Internal Medicine, Men’s Health, Metabolic Diseases, Musculoskeletal, Neurology, Oncology, Ophthalmology, Orthopedic, Pain Management, Respiratory, Transplantation, Urology / Nephrology, Vaccines, Women’s Health
The Single Interface™ offers
Proactively manage all the steps to getting sites enrolling by assigning and tracking responsibility, with alerts triggered by non-performance. Track percentage of completion by site, monitor, country or region.
Whether its Kaplan-Meier Survival Analysis in Oncology, Rater Consistency Analysis in CNS, or eye-specific analyses in Ophthalmology, each therapeutic areas requires customized reporting which Prevail can draw from its extensive library.
By providing tailored views of live study information prior to database lock, you expedite potential partnering or licensing discussions, potentially by months.
Upon receipt of safety event the platform enables instantaneous alerts to all required users without requiring human action. Complex analytics provide context to safety events and enable fast interpretation of safety labs, ECGs, diagnostics, concomitant medications and other CRF data.
The Randomization and Trial Supply Management System can be programmed to account for any study design, randomization style, number/type of cohorts, balancing of strata and decision-tree of stages.
Whether you have hundreds of sites with several degrees of separation or a particular geography of concern, metrics that track quality and detect fraud are invaluable to maintaining the integrity of a clinical study.
Site Start-up steps or documents can be grouped according to sponsor preferences and regulatory documents can be filed in an eCTD structure to facilitate eventual NDA submissions.
Products for BioTech Clinical Trials
Sound too good to be true?
Take a look at some case studies or speak with a data scientist to see if real-time data is right for your project.