ESTERN Medical Consulting works with Biotech’s, Pharmaceutical and Medical Device Companies to maximize potential and minimize risk from clinical research through development by providing expert strategic, operational and technical advice.

Building on the global reach and expertise of ESTERN Medical Consulting practice areas include Clinical Development, Regulatory and Clinical Quality Access.

ESTERN Medical is experienced in guiding clients through the clinical & regulatory process with a target strategy.

Our Clinical & Regulatory strategic planning includes our knowledge of clinical endpoints, adaptive trial design, regulatory guidelines and development trends in key drug and device indications.

• Development and Review of Informed Consent Forms
• Collection of all 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

ESTERN Medical provides full evaluation of its clients product development strategies; inclusive of screening new product concepts, evaluating clinical and clinical data, determining product need, identifying regulatory hurdles, and researching current competition on the market. In addition, ESTERN Medical will evaluate your clinical data to predict the probability of Phase II and Phase III success.

ESTERN Medical recommends sequences of Phase I-II-III clinical trial designs in recognition of the critical information that is needed to proceed most efficiently to product approval. This is done based on our experiences with the FDA/EMEA/LA-MOH guidelines as well as historical paths to approval.

Clinical trial design begins with research on the clinical setting of the product: therapeutic principles, regulatory guidance documents including product history, background literature, competing product labeling and summary bases for approval, timelines and resources. Close collaboration with the Compliance, Medical, Clinical, and Biostatistics experts leads to defined project plans for monitoring, safety reporting, data management, analyses, and quality assurance. Responsibilities for the design can be shared with the Sponsor.

ESTERN Medical can plan and design the entire device, drug or biologic trial or program. Our experience spans all therapeutic indications.

• Option Assessment Design
• Defining the Study Hypothesis
• Protocol Writing
• Case Report Form(s) Design (CRF Design)
• Investigator Meeting Planning
• Sample Size Justification
• Interim Analysis Plan Writing
• Analysis Planning
• Regulatory Guidance, Planning and Insight

ESTERN Medical works across key areas within clinical trials consulting:

We work with a diverse mix of development strategies to tackle neglected clinical, regulatory processes and recommending options for collaboration among foundations.

Landscape Evaluation, Clinical Assessment Development—To minimize an organization’s risk and optimize results, evaluating how the execute your trial and how will me the market will react to the introduction of new health interventions.

Management—Modeling, evaluating, and reshaping clinical portfolios to develop product strategies.

Organization and Performance Management —Improving the effectiveness of an organization by creating accountability and developing incentives to our Biotech, Pharmaceutical & Medical Device customers.