After public consultation, The European Directorate for the Quality of Medicines & HealthCare (EDQM) has laid down its roadmap for the submission of Certificate of suitability of Monographs of the European Pharmacopoeia (CEP) in electronic format.
The increased complexities of clinical trials in the last few years have created new challenges which require better monitoring and increased oversight to ensure higher quality conduct and better monitoring of patient safety.
As clinical trial management costs rise because of increasingly complex protocols and stringent regulatory requirements,it has become important to have proper oversight of clinical trials,programs or projects to avoid any major setbacks and to ensure the achievement of required quality,expected timelines,and return of investment (ROI).
“By 2018, over 40 countries and more than 75% of global medicine supply will be covered by one or more serialization track and trace regulations”, according to few reports.
Bio/pharma players have to postulate with challenges halting from supply chain security which goes by (product recalls, diversion) counterfeiting and rigidly accurate regulations.Moreover apprehension of safety pertains.
Centralized Monitoring: A Smarter, Cost- Efficient Approach to Clinical Quality Published in Clinical Leader.
The life sciences industry is faced with the daunting challenge of developing and introducing new drugs and therapies in a quicker and more cost‐effective ma nner. The clinical phase is the most complex part of the drug development process, and it requi res efficient planning, conducting, and monitoring of cl inical trials to achieve the de sired quality and obtain reliable study data that is appropriate for regulatory submission. Clini cal monitoring cost is one of the major costs, accounting for one‐t hird of the overall cost of clinical trial management.
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