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Its important for your clinicalresearch organization (CRO) to continually assess and invest in capabilities that help drive the success of your clinical program. There are three core areas we are strategically addressing this year. They include: 1.
Find out solutions to mitigate the impact from clinicalsupply chain risk and discover how to improve dynamic drugsupply forecasting strategies. Enrolling study subjects, setting up patient randomization and managing drugsupply are critical to the success of a clinical trial.
Approaches to outsourcing clinical trials have changed significantly in recent years. Mixing of service models — a strategy that drug developers are leveraging now more than ever — can bring life-changing therapies to market faster. Most often done using the vendor’s systems and standard operating procedures (SOP).
Regulatory Excellence - Licenses for Schedule I through IV drug substances. Adherence to harmonized pharmacy-specific SOPs based on cGMP principles at our three clinical pharmacology units. Electronic security access to the pharmacy and video monitoring. - 24/7 monitoring of temperature and humidity.
The collaboration aims to leverage Molecular Partners’ proprietary DARPin® technologies and Novartis’ broad expertise in global drug development, regulatory affairs, manufacturing and commercialization to rapidly advance the program in keeping with the unprecedented global urgency created by the pandemic.
Food and Drug Administration (“FDA”) approval. Sairiyo is advancing the clinical development of its lead drug candidate, Cepharanthine, a repurposed and reformulated naturally derived compound for the potential treatment of cancer, neurological, inflammatory and infectious diseases.
In todays clinicalresearch landscape, it is both essential and challenging to accelerate clinical trials. However, achieving this requires drug developers to navigate a highly complex and competitive environment. The challenges are compounded by increasing trial complexities.
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