At ESTERN Medical Consulting, we collaborate with Biotech’s, Pharmaceutical, and Medical Device Companies to unlock potential and mitigate risk from clinical research through development. Our expert team provides strategic, operational, and technical advice to navigate the complexities of the industry.
Core Practice Areas:
Our Consulting practice areas encompass Clinical Development, Regulatory, and Clinical Quality Access, leveraging the global reach and expertise of ESTERN Medical.
Strategic Guidance:
ESTERN Medical is adept at guiding clients through the clinical and regulatory processes with a targeted strategy. Our strategic planning includes a deep understanding of clinical endpoints, adaptive trial design, regulatory guidelines, and development trends in key drug and device indications.
Comprehensive Services:
Our services cover a spectrum of critical aspects, including:
- Development and Review of Informed Consent Forms
- Collection of Investigator Regulatory Documents
- Approval of Investigator Regulatory Packages for Release of Investigational Product
- Development and Review of Study-Specific Guidelines
Regulatory Submission Support:
- IND/NDA/PMA/510ks amendments
- Safety reports
- Annual reports
- Project Planning
Product Development Strategy Evaluation:
ESTERN Medical conducts a thorough evaluation of clients’ product development strategies, screening new concepts, assessing clinical and clinical data, identifying regulatory hurdles, and researching the market competition. We also evaluate clinical data to predict the probability of Phase II and Phase III success.
Clinical Trial Design:
Our expertise extends to planning and designing entire pharmaceutical, biologic & & medical device trials or programs across all therapeutic indications. Key activities include:
- Option Assessment Design
- Clinical Development
- Regulatory Strategy Guidance, Planning, and Insight
- Defining the Study Hypothesis
- Protocol Writing
- Case Report Form(s) Design (CRF/ECRF Design)
- Investigator Meeting Planning
- Sample Size Justification
- Interim Analysis Plan Writing
- Analysis Planning
- International clinical development project strategy
Key Areas in Clinical Trials Consulting:
We address diverse development strategies, tackle neglected clinical and regulatory processes, and recommend collaborative options among foundations. Our services include Landscape Evaluation, Clinical Assessment Development, and Organization and Performance Management to optimize results and manage clinical portfolios effectively.
Choose ESTERN Medical Consulting as your partner in navigating the intricate regulatory landscape of clinical trials. Our tailored solutions and strategic insights empower Biotech, Pharmaceutical, and Medical Device companies to achieve success in a dynamic and evolving industry.
