Biological products have unlocked the potential for the management of several diseases such as cancers and autoimmune diseases for which treatment with small molecule, chemically synthesized drug molecules remain suboptimal. According to the Food and Drug Administration (FDA) biological products…
A clinical trial is a culmination of the several stages of a drug or medical device development program that begins with the discovery of a candidate molecule followed by preclinical toxicology studies in ex vivo, in vitro, and animal models.…
A lot has changed over the past few decades in the way clinical trials are conducted. Advances in data management systems, risk-based monitoring, pharmacovigilance, electronic databases, and application of complex statistical techniques for data analysis are some of the ways…
It takes a staggering 12 years on an average for a drug to travel from the laboratory bench to your bedside! This is coupled with up to approximately $1 billion in research and development costs that a pharmaceutical company needs…
Foreign Clinical Trials (FCTs) Prior to the 1962 Kefauver-Harrison Amendments, it was uncommon for a Sponsor to submit FCTs data. In 1975 provisions that permit the submission of FCTs data not conducted under an IND were codified in 21CFR312.120. Since…
What is SaMD? Software as Medical Device, or SaMD, can be described as “a class of medical software designed to carry out one or more medical functions without the need for actual hardware. This can comprise of software or applications…
Introduction When submitting original IND applications, sponsors are expected to send their applications in triplicate (one original and two copies). Electronic submissions should be considered whenever possible. While IND application sponsors are not required to submit information regarding clinical investigators’…
“Select a Strategic Partner who can guide you through the entire Drug Development process in an Integrated Format” Introduction CRO’s are the businesses that provide support to the pharmaceutical, biotechnology, and medical device industries within the style of research services…
Developing New Drugs American consumers benefit from having access to the safest and most advanced pharmaceutical system in the world. The main consumer watchdog in this system is FDA’s Center for Drug Evaluation and Research (CDER). The center’s best-known job…
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ProRelix Research is the rapidly growing Contract/ Clinical Research Organization (CRO) with multi-country service capability supporting phase 1, 2, 3, & 4 clinical trials of Pharma, Biotech, Biopharma, Medical Device, Nutraceutical & Herbal companies to conduct in the USA, India, Europe & South East Asia.