Biopharma Industry Solutions
The journey of a novel pharmacological or biological therapeutic to market is one of many obstacles. Only 9% of new molecules and biologics make it to Phase III of clinical trials. From drug discovery to FDA approval, developing a new medicine on average takes 10 years, with a cost of $2.6 billion, which includes the cost of many potential medicines that do not make it through FDA approvals. In spite of these tremendous challenges, biopharmaceuticals companies have developed many Innovative Medicines that have drastically improved patient’s health and saved lives. We, at Clindata Insight, are committed to applying the latest statistical and computational science to support biopharma to advance the pipeline and to serve patients world wide. We are experienced with New Drug Application (NDA) of small molecule trials as well as oncology trials to FDA Center for Drug Evaluation and Research (CDER) and Biologics Licensing Application (BLA) for biologics trials to FDA Center for Biologics Evaluation and Research (CBER). We are equipped and prepared to bring in statistical and programming expertise and help you manage data-related challenges throughout this substantial undertaking, whether it is trial design issue, obtaining the necessary talent for various projects, submission data strategy, or FDA clinical data structure compliance, we can catalyze specific stages of your pathway to success.