Tracking the chain of custody for trial kits and ensuring patient data blinding – in compliance with HIPPA and GDPR – are among the unique logistical challenges to direct-to-patient clinical trials.
To manage the supply chain challenges faced by natural disasters, experts say to expect the unexpected – ensuring a strong shipping strategy is in place with temperature control and robust management.
Securing the clinical supply chain comes down to the notion of ‘compliance’, which is transitioning from a ‘nice to have’ to a ‘need to have,’ says Cryoport.
Sharp has signed a preferred partnerships agreement with an MA-based CMO to reduce “friction” for clients while decreasing the time, cost, and complexity of managing clinical trials.
CROs this month have made significant new hires with WCG adding eight to its scientific leadership team, PPD hiring four, and BioIVT filling its new-created role of CCO.
Also, making the move from Bioclinica, David Kiger has been named...
Idifarma’s seventh project with Palobiofarma will see the CDMO provide drug formulation, development and manufacturing services for respiratory disease candidate PBF-2987.
Marken is centralizing its brokerage management services in conjunction with UPS, as the rise in global trials brings more vendors and new challenges into the fold.
CPhI panelists agree that there is going to be significant consolidation in the CDMO space – and express the desire to work with fewer suppliers, the top five of which currently account for 15% of the total market.
Almac has opened a new 24,000 square foot building at its location in Durham, NC to meet demand driven by the rise in biological investigational products, says CDMO.
Metrion has bolstered its drug discovery leadership team, CluePoints has upped its RBM services, and Concept Life Sciences has added to its analytical services division, among other moves this month in the outsourced pharmaceutical services industry.
The pharmaceutical supply services provider Experic has marked its official launch with plans to construct its headquarters at a newly leased Class A research, manufacturing, and packaging facility.
The China-headquartered CDMO PharmaBlock has purchased a GMP compliant manufacturing facility and is investing in new technology and capacity to support clients long term, says chairman.
The middle-market private equity firm Nautic Partners has acquired Mikart, an Atlanta, GA-headquartered contract development and manufacturing organization (CDMO).
