Industrial Pharmacy

Clinical Studies

Clinical trial is a research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Pre-clinical research and conduct of clinical trial is also named as preclinical trials and nonclinical trials is a stage of research that begins before clinical trials, and during which important feasibility, iterative testing and drug safety database is collected. The main goals of pre-clinical trials are to determine the safe dose for First-in-man study and start to assess product's safety profile. A clinical trial is a type of clinical research that follows a pre-defined plan or protocol. Clinical trials are typically conducted in four phases, each phase is considered as separate trial and, after completion of a phase, investigators are required to submit their data for approval from the FDA before continuing to the next phase. The process of identification, analysis and either acceptance or mitigation of uncertainty in investment decision-making  Essentially, risk management occurs anytime an investor or fund manager analyses and attempts to quantify the potential for losses in an investment and then takes the appropriate action given their investment objectives and risk tolerance. Inadequate risk management and data outsourcing can result in severe consequences for companies as well as individuals. Clinical research raises profound ethical and safety questions. The protection of participants in a clinical trial is of paramount importance. With the increasing challenges associated with bringing a medical product to market, and skyrocketing R&D costs, there has been a shift in biopharmaceutical commercialization and clinical trial strategies in order to minimize risk and maximize success.  Moreover, market saturation in many disease modalities is also forcing biopharmaceutical enterprises to focus their efforts on accessing patients with orphan/rare diseases. The future of clinical trials illustrated as follows. Access and engage the patient online – Attract patients to the trial – Consent patients & convert to subjects – Remotely manage subjects & collect data.