Our Experience & Expertise

We have extensive experience working on regulatory submissions in Life Science Research and Development.

We provide Statistics and Programming contributions to project-level strategy, including the scope of deliverables, task assignment, timelines, documentation e.g., validation plans, and reporting templates.

We manage all regulatory e-submission packages and deliverables, from study data technical conformance to Define.xml and Reviewer’s Guides.

PHASE I TO IV CLINICAL TRIALS

Packages covering all aspects of phase I to IV trial delivery.

THERAPEUTIC EXPERIENCE

Oncology, Respiratory, Cardiovascular, Endocrine and Metabolic, and more.

Data Integration Services

Expert data integration advice on Integrated Safety Summary (ISS) and Integrated Summary of Efficacy (ISE).

CDISC COMPLIANCE

Ensure your data follow regulatory study data technical conformance.

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