Clinical development-

• Phase I :- Boston International Clini School’s early phase trial network offers highly specialized sites from which to choose, allowing your study to be conducted in the best possible environment. The approach is a cost-effective, highly efficient way to drive scientific breakthroughs and control costs.
• Phase II:- Globally, Boston International Clini School offers phase II clinical trial management services for all therapeutic areas. Phase II.
  Trials assess the safety and effectiveness of a new therapy for a particular disease. Furthermore, phase II clinical trials provide information on a drug’s safety and its effects on patients. In addition to regulatory affairs, we also provide site qualification, site management, clinical monitoring, data management, trial logistics, pharmacovigilance, biostatistics, medical writing, and project management services for phase II trials.
• Phase III:- Across all therapeutic areas, Boston International Clini School provides full clinical trial management services for phase III studies. In phase III trials, drugs are definitively evaluated for their effectiveness in treating a disease. As these studies usually involve more patients and require more time to complete (usually 300+), they are more complex than those in other phases
• Phase IV:- Across all therapeutic areas, Boston International Clini School provides clinical research management services for late phase studies. Studies conducted in the late-phase (phases III and IV), as well as observational studies, are designed to determine whether a drug will have a longterm effect on a patient’s quality of life and its efficacy over the long term.
• Data Management:- Having clean, reliable data is crucial to the success of your trial. Boston International Clini School clinical data management team is dedicated to simplifying the collection and management of clinical data to give you the results you need. By combining the latest technologies with our collective knowledge and expertise, we are able to identify and resolve discrepancies, ensure data quality, and develop and implement quality solutions.
• Medical Writing :- Globally, Boston International Clini School provides high quality writing services for Biotech, Pharmaceutical and Medical Device companies. We have experienced and qualified Medical Writers who can produce a wide range of Regulatory, Clinical, Scientific, and Marketing communication materials. Our medical writers can prepare clear, concise, and high-quality documents and reports to be submitted to regulatory agencies, published in peer-reviewed medical journals, and communicate effectively throughout your marketing campaigns.
• Quality Assurance:- all rules and regulations are followed by Boston International Clini School’s Quality Assurance team. Every step of the clinical trial is monitored according to stringent Standard Operating Procedures (SOPs). Pharma (Clinical research) follows the International Conference on Harmonization – Good Clinical Practice ICH – GCP for quality assurance. Globally, these practices are used to assess the risks associated with a proposed trial, assess the quality and accuracy of data, ensure ethical project processes, and ensure regulatory compliance. Through regular audits, we ensure that clinical trial team members follow best practices.
• Regulatory Affairs:- Boston International Clini School offers regulatory services to facilitate all stages of drug development. In order to achieve this, we provide interdisciplinary strategy planning so that we can obtain the most effective and efficient regulatory pathway to regulatory approval. As of now, we have achieved a 100% success rate in obtaining regulatory approvals.