Clinical news roundup for the week of November 6th with information on FDA funding pediatric trials, clinical trials for heroin addicts, Marken’s home delivery app, Seeker’s patient enrollment portal, and minority recruitment in trials.
In the last few years there has been significant buzz in the life sciences industry surrounding the use of wearable devices that can be utilized for remote patient monitoring in clinical trials. Many believe wearables have the potential to significantly impact overall trial costs and efficiency, and recently they have returned to the spotlight due to fresh approaches that harness artificial intelligence/machine learning.
Clinical News Roundup for the week of October 23, 2017 with information on CRS’ lawsuit against the FDA, FDA boosting patient access to medical devices, the Bracket acquisition of mProve, why Alzheimer’s drugs fail, and more.
The watchdog group Center for Responsible Science (CRS), along with clinical trial participants and the father of a deceased trial participant, has filed a lawsuit against the FDA for denial of CRS’ citizen petition, which was originally submitted in June 2014 and has since had several amendments.
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.
This paper discusses some of the challenges of traditional paper-based TMFs and provides details about PhlexEview, Phlexglobal’s eTMF system. It also suggests a new approach to TMF compliance that extracts and sets the expectation for continuing value from TMF content, rather than locking it away in paper storage where its value is minimized. By Karen Redding, Global Business Development Director, Phlexglobal, Ltd.
PhlexEview supports compliance and collaboration by leveraging industry standards and making TMF content available to users, regardless of their location. The ability to access and view TMF content at any time transforms sluggish and inert paper processes and helps organisations to realize time and cost savings by reducing travel costs, positioning team members to proactively identify compliance issues and implement corrective actions and by facilitating global collaboration.
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.