The FDAAA Title VIII, which required clinical trial results to be disclosed on ClinicalTrials.gov, went into effect in September 2007. The industry has now reached the 10-year anniversary of the act, which is a good time to reflect on progress that has been made and whether the requirement has actually improved transparency in clinical trials.
Regulatory experts outline some of the regulatory changes on the horizon for the medical device industry.
The recent announcement that the watchdog group Center for Responsible Science (CRS) has filed a lawsuit against the FDA has raised some concerns in the clinical research community. The lawsuit is regarding the denial of the group’s citizen petition, which was originally submitted in June 2014.
Randomized clinical trials (RCTs) of prescription drugs and other medical products have been considered the gold standard of evidence to support decision making by clinicians and policymakers. However, it is increasingly recognized that most RCTs are unable to generate information about a product’s real-world effectiveness. Measures such as long-term outcomes, comparisons among multiple treatment options, and utilization are not well captured in trials. Furthermore, benefit-risk balance and value for money are best learned in cost-effectiveness or cost-benefit analyses.
Long-standing global relationship and history of quality important factors in selecting their partner to process foreign cases for PMDA submission for studies.
SynteractHCR is a multinational clinical research organization, formed from the merger of Synteract with Harrison Clinical Research in 2013, which provides global, full-service clinical trial services. We have more than two decades of experience supporting biopharma companies in all phases of clinical development across multiple therapeutic areas. We customize programs that will deliver timely, high quality data to help you get to decision points faster, taking time and cost out of drug development.
As FDA guidelines evolve and drug products on the market begin to age, Bio/Pharmaceutical manufacturers face scrutiny of the original methods used to support these products. Therefore, manufacturers must re-evaluate these methods to ensure they comply with current FDA expectations.
In July 2012, a series of pharmaceutical legislation became effective in the European Union (EU), which included new requirements for Marketing Authorization Holders (MAH).
A small biotech company partnered with Chiltern to perform full services across over 15 projects for their entire clinical program in retinal indications starting at Phase II.
It’s a chilling fact: One irresponsible company could seriously damage, or even destroy the biosimilar field. A single company cutting corners with under-regulated, lower-quality development could create an inferior product that harms or kills patients.
Omeros Corporation (NASDAQ: OMER) today announced that its Investigational New Drug Application (IND) to evaluate OMS824 in Huntington's disease has been cleared by the U.S.
DATATRAK International, Inc. (OTCQX: DTRK), a leader in developing cloud-based, unified eClinical® technologies and delivering related services for the clinical trials industry, today announced its operating results for the first quarter of 2013.
Oracle and Proteus Digital Health announced recently that Oracle has made a strategic minority investment in Proteus, a leading digital health company.
NextDocs announced the release of NextDocs 6, the latest version of its award-winning regulated content management and compliance suite.
TransPerfect, a leading provider of solutions for global development and commercialization of products to the life sciences industry, announced that Aptalis Pharma ("Aptalis") has implemented Trial Interactive as its global pharmacovigilance system master file (PSMF) solution.
DATATRAK International, Inc. (OTCQX: DTRK), a leader in developing cloud-based, unified eClinical™ technologies and delivering related services for the clinical trials industry, today announced its operating results for the fourth quarter and full year of 2012.
CFS Clinical (CFS), a specialty provider focused on the business and financial management activities for clinical trials, recently announced the launch of its upgraded technology platform and new tax consulting services.
Mesoblast Limited (ASX:MSB) (OTC ADR:MBLTY) today announced that United States Food and Drug Administration (FDA) is in agreement for Mesoblast to supply its proprietary Mesenchymal Precursor Cells (MPCs) for clinical trials in the United States under Investigational New Drug (IND) protocols, from Lonza's contract manufacturing facility in Singapore, in addition to its United States facility.
CRF Health, the developer of the TrialMax® Suite of electronic Clinical Outcome Assessment Solutions (eCOA) for the life sciences industry, becomes the first eCOA company to complete a full validation study for Professor Juniper’s ACQ and AQLQ questionnaires to the “Gold Standard” based on her recently released “Levels of Acceptability of Electronic Versions” rating system.
DATATRAK International, Inc. (OTCQX: DATA), a leader in developing cloud-based, unified eClinical® technologies and delivering related services for the clinical trials industry, today announced it will soon be trading as DTRK.
Mission3, the Premier Regulatory Information Management provider for the Life Science industry will be exhibiting at the upcoming 2012 RAPS – The Regulatory Convergence Conference. The company will have a booth set up in the exhibit hall (#224) and have team members attending the educational sessions.
Bioanalytical and pharmacokinetic specialty Contract Research Organization (CRO) MicroConstants announced today the successful completion of a five-day inspection by the United States Food and Drug Administration (FDA) for compliance with Good Laboratory Practice (GLP) regulations.
Merge Healthcare Incorporated, a leading provider of clinical systems and innovations that seek to transform healthcare, recently announced that Datapharm Australia Pty Ltd. has selected Merge’s eClinical OS™ solution to bring EDC in-house and provide control of electronic case report form (eCRF) creation and mid-study adjustments.
Five executives representing regional and national companies will receive Star Developer awards in recognition of their work to develop future leaders. The awards will be presented in October by The Professional Development Group, an executive coaching firm.