Strategic Consulting Services
ClinicalRM’s Medical Experts Office (MEO) is a central alliance of therapeutic expertise, comprised of world-renowned physicians and scientists, providing a single point of access for customers seeking rapid medical expertise and guidance for drug development. The MEO includes physicians and scientists with decades of experience in clinical research and product development. With the MEO’s experience in research and development, we have built a network with development-experienced consultants offering guidance to our clients on a wide range of development areas and indications. Our regulatory and strategic development team provides consulting for pre-clinical, manufacturing, and clinical development of therapeutics and vaccines. Our advisory services are focused on creation and execution of pre-IND through End of Phase 2 strategy that minimizes time to proof-of-concept in the clinic. Value is built through careful and informed decisions about resource allocation, study design, manufacturing, and integrated timing for a program that gives the product the best chance for success, maintains safety and compliance requirements, and manages money allocation to maximize the ROI. We can develop regulatory submissions in the US and across Africa. This may include providing regulators and investors with pre-INDs, INDs, Phase 1 and Phase 2 protocols, coordinating KOL meetings, and providing strategic guidance to assure success in the clinical.
We help you:
- Design studies and whole clinical programs that accelerate your path to proof of concept.
- Limit pre-clinical studies to critical requirements to avoid ballooning non-clinical study costs and timeline delays.
- Achieve tactical management of technical challenges through contextualization and impact mitigation rather than more studies.
- Gain FDA designations such as Fast Track and Breakthrough Therapy.
- Choose patient populations, clinical sites, investigators, surrogate endpoints, and trial designs that allow a meaningful initial assessment of efficacy early in the development life-cycle (Phase 1 or Phase 2)