Industry have seen evolution of clinical trials from normal Site Based Activity to Risk Based Monitoring which is further evolved to Patient Centric and Virtual Clinical Trials.
This brings a huge challenge and opportunities for service industry to keep offering solutions suited for next level of challenges. Cost effectiveness and high success rate is very important.
Biosimilar is next level of evolution in overall Pharmaceutical Industry. This becomes so important from the perspective of access low cost/ affordable medicines in Western Europe and USA. Today Biosimilars find good footprint in Europe, whereas in the USA it has just started its journey. Reimbursements & Incentives Policies, Market Access & Approval, Reference Drugs, Interchangeability, etc. are always big challenges for any manufacturer.
For any manufacturer certain factors such as QA Suppliers, Proper Supplies, Process Development, Analytical Development, Raw Materials, Supply Chain Management, Cost Structure Analysis, etc. are key factors for evaluation of setting up effective process in place.
Chemical and Biological APIs possess different set of challenges, and supply chain industry is evolving very fast in US, Europe, India, and China.