Phase II & Phase III Services offer a broad range of data for the validation of drug entity for the global healthcare/ pharmaceutical industry. These services assay validation leading up to Phase I/II and III clinical trials, and help to navigate pharmaceutical companies through the often complex, regulatory challenges of the drug approval process.
Clinical trial development of new medicinal products is often complex and challenging, and that quality and regulatory compliance are integral to the overall outcome of your clinical study, from IND, to NDA/BLA submission and all the way to commercialization.
Combining scientific leadership with disciplined execution, global access to patients and local / global regulatory expertise always speed up the compound on the path to approval.
Full-time physicians provide strategic direction for study design and planning, train operations staff, work with primary investigators, provide medical monitoring, and meet with regulatory agencies. Trial design and execution are two of the major standpoints for a CRO to conduct these trials at key sites globally.
Close collaborations and ongoing programs with high recruiting sites at academic, network, and independent centers (GCP Compliant) with in house contract attorneys to expedite contract negotiations and final executions are the signs of a good CRO.Proprietary, integrated clinical study management technology platform facilitates efficient execution of global trials with personnel experienced in Data Safety Monitoring Committee management as well as providing on-going statistical support.
Site selection process and protocol design is always dependant on the long term strategy of the pharmaceutical/ Biotech Company.
Phase II – III studies across all major therapeutic areas, including immunotherapies, oncology and rare and orphan diseases are done with a strong focus on safety. Multiple software and technology platforms are used to deliver high quality data and robust biostatistics services, on time and without surprises.
During the part of journey from Proof-of-Concept through regulatory submission, Phase II-III specialists optimize every step of clinical trials by every means possible.
For the successful placement of multinational trials, CRO’s provide you with all relevant information, not only on epidemiology and suitable investigators, but also on the regulatory environment, health care system, local therapeutic guidelines, or potential competitive projects. International multicentre phase II and III trials are challenging for the sponsor, due to differences in language, health care systems, regulatory environments, medical practice, and cultural background.
Appropriate technologies and IQ systems enables easy visualization of data and metrics at a study and programme level. Full data-related support, including clinical data management, biostatistics, statistical programming, medical writing and pharmacovigilance are also major components of clinical trials. Working with the right strategic partner during later stages of product development, can help manage cost, reduce risk and ensure all deadlines are met.