Deloitte’s acquisition of QSpace expands its IT quality and compliance solutions offering for life sciences firms, including contract research and manufacturing organizations.
Japan-based ONO Pharmaceutical will use CluePoints’ centralized statistical monitoring platform to lead its RBM strategy over the next four years following a successful pilot study in 2017.
China has announced that it will now accept clinical trial data from other countries in a new guideline that aims to reform the management of clinical trials.
The EMA recently updated its Good Clinical Practice (GCP) Q&A to address several contractual arrangement “pitfalls” – specifically with electronic systems vendors.
As 20 of the largest biopharma companies have now joined industry group TransCelerate, the group is beginning to use patient centricity and connectivity to influence the clinical trial environment, CEO Dalvir Gill told attendees at the Partnerships in...
The trade organization Society for Clinical Research Sites (SCRS) has broadened its relationship with PPD subsidiary Acurian to initiate a Site Advocacy Group (SAG) focused on global patient recruitment.
The US FDA is looking to set up master protocols that can continuously run and help cut down on waste that’s prevalent in the clinical trial industry, Director of FDA's Center for Drug Evaluation and Research Janet Woodcock said in an interview.
Indian regulators have accused a hospital of conducting unauthorised clinical trials of stem cell therapies and of charging patients who took part for the treatments.
Concerns over India-based GVK Biosciences have been raised in a letter from France’s ANSM (Agency for Medicines and Health Products Safety) to marketing authorization holders following a GCP (good clinical practice) inspection citing deficiencies in the...
A Swiss association has recognized the European Centre for Clinical Research Training (ECCRT), a SynteractHCR company, for training investigators and sub-investigators on GCP (good clinical practice).
Parexel has teamed up with Japanese trial management services firm Fuijitsu Systems West in an agreement that underlines the CROs eClinical growth ambitions in Asia.
The US Association for the Advancement of Medical Instrumentation (AAMI) has adopted the latest version of the ANSI14155 standards for medical device trials.
Marketing applications should contain details of clinical trial ethics and be rejected if serious violations are found, said some EMA workshop participants.
The EMA inspects fewer than 1% of trial sites. Outsourcing-Pharma visualises this data and details the GCP-compliance sampling and collaboration strategies used by the EMA.
An urgent overhaul of ICH GCP is needed to “reverse the harm” caused by guidance that is bureaucratic, wastes resources and impedes scientific progress, according to a journal.
The EMA has published its thoughts on monitoring overseas trials and will seek to establish an international network of regulators to develop and implement a robust oversight framework.
Contrary to fears, the European Union’s Clinical Trials Directive has not had an inhibitory effect on the number of studies carried out by publicly-funded researchers, at least in Denmark.
