VP, Marketing and Business Development, Ropack Pharma Solutions
The road to drug approval is long, expensive – and crowded. As of March, 2015, ClinicalTrials.gov reports that there are already 182,437 registered clinical studies so far this year. That’s more than twice as many as the 83,452 studies registered during all of 2009. This burgeoning clinical activity is not just driven by large pharmaceutical organizations but also impelled by emerging pharma and biopharma companies.
With competition fierce, reaching the finish line – final approval – requires identifying and utilizing efficiencies of time and money while maintaining security, traceability, quality and reliability. Because clinical trial studies are often international in scope, sponsors or pharmaceutical companies often reach out to global CMOs to manage trials. A key factor in supporting those clinical trials and delivering cost and time savings is to secure an in-country clinical material partner who can consolidate shipments, packaging, warehousing, distribution, collection and destruction in one location.
In-country partners move forward the clinical trial process at an accelerated pace by consolidating in-country shipments to one location, assisting with the laborious regulatory paperwork and the bureaucracy that can impede progress and consume valuable time. Documentation as well as import/export activities are simplified when reliably handled by an in-country partner already familiar with these procedures.
When pharmas or CMOs send bulk trial materials to an in-country depot, all of the packaging components can be sourced locally, dramatically reducing shipping costs. Warehousing of product takes place in an audited and reliable facility and distribution from within the country – to hospitals, clinics and patients – is yet another means of controlling bottom-line expenditures. Benefits of Using an In-country Clinical Trial Material Depot Collection of used and unused materials and subsequent destruction follow all regulatory protocols.
While the advantages of reduced regulatory barriers and reduced logistical problems are a valuable asset to CMOs, large pharmas that manage their own clinical trials should consider the beneficial option of an in-country clinical trial material depot as well.
Time is money, especially with clinical studies. It is a race to the finish line. Each day that can be eliminated from the go-to-market timeline brings significant bottom-line results. An in-country clinical trial material depot is a wise choice on the fiercely competitive road to drug approval.
Like what you read? Share with your network:
Paul Dupont is V.P. Marketing and Business Development for Ropack Pharma Solutions which provides solid oral dosage drug development from early-stage formulation development through commercial launch. RPS operates production facilities in Montreal Canada and Long Island, NY, Dupont has more than 20 years’ experience launching new business development initiatives in the food, pharmaceutical and consumer healthcare industries and expanding market presence to new geographic territories.
VP, Marketing and Business Development
Email Paul Dupont
Download the File