Design a robust clinical development plan
How do you ensure that the design of your program is both efficient and effective? It is imperative to have high-quality medical and scientific input into your clinical development strategies.
サターラの臨床サイエンティストは、最初から最後まで臨床を監督し、お客様の目標を達成するために臨床開発プログラムを設計します。
Medical and scientific input throughout the entire lifecycle
- Develop a solid target product profile (TPP)
- Build translational components for proof of mechanism, proof of concept, clinical study design, exposure and dose-response strategies and personalized healthcare
- Create development plan, protocol design and clinical study reports
- Advise on relevant clinical endpoints, surrogate endpoints (biomarkers)
- Engage in key opinion leader interactions and convene advisory boards
- Advise on late-phase innovative study designs
- Support market access strategies (RWE / HEOR, PROs and model-based meta-analysis)
Your first choice end-to-end partner
Creating unquestionable value for our partners is our #1 priority. We work side-by-side as members of your team and can even support you in regulatory interactions on clinical safety and efficacy, as we have many times before for our clients.
We can take on safety oversight from start to finish. We provide clinical therapeutic and safety evaluations in due diligence asset assessments and review and compile safety and efficacy data for manuscripts and publications.
Dr. Marshall is a fellow of the faculty of pharmaceutical medicine at the Royal College of Physicians and has over 30 years of experience in the pharmaceutical industry preluded by clinical practice. At Certara, Dr. Marshall is responsible for growing the clinical science group of senior-level scientists and physicians, which drives clinical and medical elements of Certara’s consulting offerings to clients.
A trained pharmacist and scientist, Malavika accelerates drug development by leveraging modelling, simulation, and expert consulting services throughout the drug life cycle. She provides clinical and regulatory intelligence to support regulatory submissions, drug development, gap analysis, and TPP creation. Malavika has deep experience in drug-drug interactions and drug-gene interactions.
Ryan supports the clinical science group as well as other Integrated Drug Development (IDD) functions in support of client projects. He provides assistance to the VP of Clinical Science, Medical Directors, Clinical Operations, and subject matter experts from other IDD functions by providing input into scientific aspects of clinical trial study design and by supporting the scientific writing elements of various clinical technical documents.
Dr. Marshall is a fellow of the faculty of pharmaceutical medicine at the Royal College of Physicians and has over 30 years of experience in the pharmaceutical industry preluded by clinical practice. At Certara, Dr. Marshall is responsible for growing the clinical science group of senior-level scientists and physicians, which drives clinical and medical elements of Certara’s consulting offerings to clients.
A trained pharmacist and scientist, Malavika accelerates drug development by leveraging modelling, simulation, and expert consulting services throughout the drug life cycle. She provides clinical and regulatory intelligence to support regulatory submissions, drug development, gap analysis, and TPP creation. Malavika has deep experience in drug-drug interactions and drug-gene interactions.
Ryan supports the clinical science group as well as other Integrated Drug Development (IDD) functions in support of client projects. He provides assistance to the VP of Clinical Science, Medical Directors, Clinical Operations, and subject matter experts from other IDD functions by providing input into scientific aspects of clinical trial study design and by supporting the scientific writing elements of various clinical technical documents.
How can we advance your program?
お問合せ iddconsulting@certara.com
