From lab to clinic to approval and launch- WE AIM FOR YOUR SUCCESS! “Why use a boutique subject matter expert consulting firm? Based on more than 30 years of international pharmaceutical research and commercial development experience we believe there is greater complexity, competition, costs and risks in translational medicine and clinical development. The most common underlying factors for development delays and failures involve gaps and limitations of in-house know-how, and failing to take into account critical medical, scientific, regulatory and competitive considerations. We believe it is very hard to find experienced medical and global commercial drug development talent. There is strong evidence that there are significant knowledge deficits in translational medicine and scientific commercial development; this is apparent given the high proportion number of development delays and product failures that occur.

Our advantages

Competitive strengths in preclinical translational medicine
Our competitive strengths in preclinical translational medicine and global commercial pharmaceutical development include expertise in the following service areas: GAP and Risk Analysis of preclinical in vitro/in vivo assessment of MOA, safety, identifying and justifying a safe starting dose and dose escalation scheme, pharmacology, pharmacodynamics, trial design and endpoints and identifying and optimizing safe and effective dose levels, prioritizing target patient populations, competitive analysis, drug testing in relevant animal models, PK assay and testing assessments, regulatory meeting preparation and guidance.
We can identify and solve GAPs and risks in the Sponsor’s development programs and help them to achieve their development objectives cost effectively.
Global commercial IND/Phase I-III and NDA/BLA development in the US, China, Europe, Japan, and ROW.
Due diligence, GAP and risk assessments; solutions/mitigation.
Competitive strengths in commercial clinical development
We are very experienced in the design, management and conduct of Phase I-III international trials including US, China, EU, Eastern Europe, and APAC, with more than 30 years of global experience in commercial oncology development as well as other therapeutic areas.
Our trial designs and protocols stand out from the competition; we customize and align the trial design and protocols to match the science, the commercial development strategy, the current vs. the envisioned future SOC to support successful approval based on the Sponsor’s objectives and resources.
We can identify, and manage the process and performance for cost-effective bid competitions and contracts between CROs and vendors to optimize costs, time, risks and quality of their services. We can also manage these third parties cost-effectively throughout the performance of the clinical trial.
Due diligence, GAP analyses, risk assessment and mitigation solution.