DRUG DEVELOPMENT consultancy

We offer strategic consulting at every stage of a product’s lifecycle, from due diligence through
all clinical development phases and into the peri/post-approval period. We aim to solve all of the
medical/scientific and operational challenges that biopharmaceutical companies face throughout
the development process. Therefore, we see ourselves very much as a partner to our clients
and ensure that their resources and budgets are appropriately allocated at critical stages of the development process. Our services include:

• Due Diligence
– Combination of medical and scientific due diligence with a broad view of the challenges and costs of a full development program.


• Strategic consulting and program/study design
– Design and ongoing oversight support for pre-clinical as well as Phase I through Phase IV clinical trials.
– Design and operational support of pre-clinical, Phase I and Phase II studies including ADME (absorption, distribution, metabolism, and excretion), Pharmacokinetics (PK), PK-pharmacodynamic correlation, proof of concept and special population assessments.


• Operational Services
– Feasibility assessments and detailed budgetary modeling which help define an optimal balance between the number of study sites, patient recruitment rate, geographic scope of the program and cost
– Data Monitoring Committees (DMCs) and Endpoint Adjudication Committees produce charters, recruit members and manage the entire committee process.


• Peri- and Post-Approval needs
– Design and conduct peri- and post-approval patient registries to support product safety and help meet strategic marketing and communications needs.

Regulatory consultancy

Encorium is experienced in providing clients involved in the Research and Development of medicinal products with advice and support services in the planning of their development programs.

This may cover review and preparation of the documentation on quality (drug substance and drug product), nonclinical and clinical. This includes regulatory consultancy on study design and clinical program to achieve optimal timelines for clinical trial authorisation approval.

These services are of relevance to companies within the EU who wish to broaden the fund of development experience contributing to their programs, and also to non-EU companies who wish to retain local experience when placing development work in Europe.
Areas of service include:

• Review and advice of quality, nonclinical and clinical programs in relation to regulatory requirements
• Advice and support on a global development program, with regard to acceptability of foreign clinical data and need for bridging studies
• Organization of scientific advice consultation with competent authorities (EMEA, EU local authorities, US FDA)
• Preparation of IMPDs, Investigators’ Brochure

consultancy experience

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