Our Services

bioRASI

The Translational

Clinical Development CRO

Program Management ranges from an in-depth analysis of the sponsor’s therapeutic candidate development Program to developing optimized Program components, IND enablement, regulatory, and clinical strategies. Our Program managers assemble and skillfully manage project resources ensuring the optimized fulfillment of the overall programs.

Text Box: bioRASI routinely provides a full range of services for a complete therapeutic development program from bench to bedside all the way to establishing clinical proof. We also commonly support our sponsors’ functional outsourcing model, providing the necessary provision of services with the same dedication and commitment to quality. In every case our unrivalled knowledge base and experience significantly accelerates the drug development process.

bioRASI is a FULL SERVICE CRO providing services out of its five major service branches:

Our Services

Program Management

Regulatory services covering the implementation of regulatory strategies as well as seeking and obtaining of approval from, and trial interface with, numerous would-wide venues.

Regulatory

Clinical

Compliance & Audit

Data Management & Analysis

Clinical services covering the site selection and monitoring of single or global multi-center trials as well as dealing with site and staff training, issue resolution, and all of the necessary steps to ensure the highest quality of the intervention and data collection.

Data Management and Analysis ranging from trial design to CRF and data capture, all the way to SAS analysis and final report development; all performed in a 21 CFR Part 11 compliant manner.

Compliance and Audit services dealing not only with internal QA and audits by third parties, but also with auditing third party trials for Sponsors world-wide.