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
Additional information on FDA's draft guidance is available in our preceding FDA News article, entitled "FDA Expands on Recommendations Regarding Use of EHR Data in Clinical Trials, Part One:...
Clinical Research Solutions
On Tuesday, May 17, FDA announced the availability of a new draft guidance, entitled “Use of Electronic Health Record Data in Clinical Investigations.” The document, which expands on the...
Clinical Research Solutions
On Thursday, May 12th, the FDA issued a warning regarding fluoroquinolone antibacterial drugs, stating that the associated side effects “generally outweigh the benefits for patients with sinusitis,...
Clinical Research Solutions
Implementing and maintaining a Quality System is a complex challenge. It is as much as an art as it is a science. A company’s Quality System establishes the framework to manage and maintain...
Clinical Research Solutions
On May 5, 2016, the FDA published a final rule, extending the Agency’s authority to all tobacco products, including, but not limited to, e-cigarettes, cigars, and hookah and pipe tobacco. This rule,...
Clinical Research Solutions
Additional information on FDA's draft guidance is available in our preceding FDA News article, entitled "FDA Guidelines for Post-Approval CMC Changes, Part One: Overview of the Updated Draft...
Clinical Research Solutions
For those of you unaware, the FDA submitted a draft guidance on data integrity for comment in April. This is significant in that the last formal written guidance provided from FDA on this subject...
Clinical Research Solutions
On April 19, 2016, FDA released a revised and updated draft guidance entitled "Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information," which...
Clinical Research Solutions
On Friday, April 29th, FDA’s Center for Biologics Evaluation and Research (CBER) announced the availability of a new program supporting the submission of vaccine adverse event information. 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...