Clinical Research and Clinical Trials.
Clinical Trials help evaluate a new drug, a medical device or a therapy’s goal to perform its intended service before its market launch. We, at Amtex, understand quite well, these data- intensive trials comprise vulnerability to accuracy and outcomes thus rendering their conduct, review, analysis and reporting a time-consuming and expensive endeavor to sponsor- organizations and CROs.
The advent of Information Technology and Data Science in the recent years helped enhance the operational aspects of clinical trials with improved planning and processes. CROs and research sponsors are turning to web-based applications to manage Clinical research and trials. Clinical Trial Management Systems (CTMS), software-based Case report forms (CRF), Electronic data capture (EDC), Electronic patient-reported outcome ePRO, Electronic clinical outcomes assessment eCOA are changing the Clinical Trial eco-system. Increased use of SAS programming, Statistics and data analytics help in visually-rich reports for regulatory compliance and submissions.
Our association with [Bio]Pharmaceutical and Biotechnology organizations for over a decade to providing Clinical Research professionals including Clinical Trial phases I-IV has helped us to collaborate with the best Life Sciences talents cutting across any therapeutic space of Clinical Operations, data-driven analytics, SAS Programming, Statistics, Regulatory Affairs, Medical Writing, Quality Assurance, Drug Safety and Pharmacovigilance.