ProPharma’s team of dedicated experts is at the forefront of both existing and emerging industry trends. ProPharma’s team inspires tomorrow by leveraging rich data insights across our service lines and functional areas to develop innovative solutions that answer the most complex needs of both existing and prospective clients.
Clinical Research Solutions
On November 3, 2015, Tufts Center for the Study of Drug Development (CSDD) published its November/December Tufts CSDD Impact Report. According to the report, when “first-in-class” drugs receive...
Clinical Research Solutions
Last year, FDA published a draft guidance entitled, “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception.” The document is presented...
Clinical Research Solutions
On Friday, October 30, 2015, FDA released a draft guidance, entitled “Bioequivalence Recommendations for Progesterone,” in which the Agency offers product specific guidance on the design of...
Clinical Research Solutions
Issues for Sponsors with INDs and CMC concerns FDA recently released a draft guidance entitled “Recommendations for Microbial Vectors Used for Gene Therapy” as a supplemental guidance to “Guidance...
Clinical Research Solutions
On August 28, 2015, FDA published a draft guidance entitled “Nonproprietary Naming of Biological Products.” If finalized, the draft guidance will establish a naming convention for biosimilars. The...
Clinical Research Solutions
Published on October 27, 2015, the guidance document outlines a number of recommendations for the nonclinical evaluation of previously approved drug substances when a new formulation or a new route...
Clinical Research Solutions
In the space of a few years, Medical Information outsourcing has moved from being a last resort to become a core part of the service delivery strategy for most pharmaceutical companies. The speed of...
Clinical Research Solutions
Yesterday, FDA Acting Commissioner Stephen Ostroff, M.D. spoke at the RAPS Regulatory Convergence, where he highlighted various events leading to the transformation taking place within the Agency....
Clinical Research Solutions
On Tuesday, November 17, 2015, the House of Representatives’ Energy & Commerce Committee will hold a hearing entitled, “Examining the Regulation of Diagnostic Tests and Laboratory Operations.” The...
Clinical Research Solutions
Part 1 of this series discussed confidence intervals. Confidence intervals are the best known of the statistical intervals but they only bound regions associated with population parameters; i.e., the...
Clinical Research Solutions
In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...
Clinical Research Solutions
What is a Clinical Study Report? A Clinical Study Report (CSR) is a document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related...
Medical Information
Patient Support Programs (PSPs) in the pharmaceutical sector represent an array of aimed at supporting patients in initiating therapy and maintaining adherence. PSPs, also known as Patient Assistance...
Clinical Research Solutions
The link between statistical methods and healthcare is not a new one, but the volume of available data to inform healthcare decisions and the use of data science in the medical industry has exploded...
Regulatory Sciences
This article has been updated since its original February 28, 2017 publication. Since the introduction of the Prescription Drug User Fee Act (PDUFA) VII for fiscal years 2023 - 2027, the FDA...