As a global digital contract research organization (CRO), we specialize in providing a full complement of strategic drug development services to emerging and mid-tier life science firms.
Our experts brings extensive therapeutic experience in building a well-defined strategy and operational plan to ensure the success of your drug candidate throughout its development lifecycle.
We offer clients drug development services covering the following activities:
- Clinical Development
- Regulatory Consultancy
- GxP Auditing & Quality Assurance
- Chemistry, Manufacturing & Control (CMC)
- Medical, Scientific, and Technical Affairs
Clinical Concept Consultancy
Working as a collaborative team, our medical experts work with you to ensure that your clinical development program can be operationalized, including:
- Development of clinical strategies and clinical operating plans – from “scratch” or as an extension to new indications or formulations
- Development of clinical study protocols – narrow down appropriate hypotheses, objectives, selection of adequate measures to a methodologically valid design and complete protocol
- Assessment of a therapeutic area, competitors, opportunities and threats for your own product, and identification of USP (unique selling points) – in order to optimize your success