Every pharma or biotech company requires a straightforward, fast and cost-effective development path for its pipeline products. A critical component of this pathway is detailed comprehensive planning of the clinical development program. We understand this process and for all our studies we actually “walk the path” of what it takes to move your product through the hurdles, identifying in advance all risks and potential gaps in the process. The start of every project and recruiting the first patient is a major milestone. We believe that by thorough and adequate pre-planning and carefully mapping the A to Z of securing the first patient we save our clients’ time and budget.
The majority of our personnel have worked in large and small pharmaceutical companies and in international CROs, and have a thorough understanding of the costs, time and challenges in progressing a product from research through to marketing authorization. Our expertise spans all stages of the clinical drug development: from selection of study type and patient population to selection of countries with the most effective ratio of costs, quality and timelines of a clinical study, to project management, analysis and registration of a product. Moreover, we have built considerable expertise in identifying, recruiting and retaining eligible patients, a key challenge in all studies.
Services related to advice on clinical development programs include:
- Consultation on study types required for drug registration
- Development of study design and outline with core elements
- Negotiation with regulatory authorities on study design
- Discussion of study concept with world and national opinion leaders
- Capability of study execution in various countries
- Budgeting of study-related activities
- Advice on designing one clinical program to achieve multiple global approvals (e.g., US, EU, Russia)
Our team would be glad to assist you with our professional advice – please contact our Business Development team.