Researchers used pre-existing platforms to identify and recruit patients for a cancer research study – connecting advocacy groups, social media, and a dedicated website to register patients.
A revised concept paper on first-in-human trials will be ready next month according to the EMA which is reviewing the French Phase I trial in which one volunteer died in January.
A real-world trial of GSK's Relvar has prompted the development of a ‘game-changing’ database linking and tracking tech according to North West e-Health.
Industry backing for a G7 plan to preserve antibiotics is at odds with current marketing practices says an NGO calling for a clamp down on campaigns that promote overuse.
Rising drug prices and the subsequent increasing number of drugs ineligible for reimbursement will challenge drug developers to provide clinical superiority evidence.
Patients must be more involved in trials according to ex Google Chief Health Strategist, who told sponsors and CROS that increasing engagement is key to moving forward.
French investigators reviewing the Phase I trial in which one volunteer died and five others were hospitalized in January have criticised CRO Biotrial over how it conducted the study.
Clinical Trials Day celebrates the first randomized clinical trial conducted in May 1747 and the clinical research professionals that work in the industry more than 265 years later.
This month marks the renewal period for Pfizer’s contract research organizations’ Icon and Parexel, and while revenues have been declining, analysts believe the pharma giant will renew with both companies.
Swedish regulators have withdrawn a GMP certificate issued to Bend Research after deeming the firm’s plan to address deviations at its Oregon plant “partly unacceptable.”
In an effort to improve transparency in clinical trial research, two doctors created a system that coverts trial documents into a Bitcoin – an online equivalent of cash.
BioLife Solutions has partnered with transportation firm MNX and says it expects increased demand for its biologistics services as more cell therapies enter the clinic.
Innopharma has teamed up with Glatt to offer Indian drugmakers process analytical technology (PAT) tools it says can reduce costs and increase compliance.
VistaPharm has recalled thousands of cases of generic oxycodone as a result of a defect that allowed the powerful painkiller to leak out of the packaging.
A remediation plan by Medreich Limited is sufficient to bring its Andhra Pradesh antibiotics plant in to compliance with GMP according to French regulator ANSM.
Drug companies will prioritize the EU over the UK in the event of Brexit according to the ABPI, which says members recognize the benefits of centralised licensing.
Inadequate record keeping at Merck & Co.’s contract manufacturer has delayed the European launch of its hepatitis C drug Zepatier (elbasvir and grazoprevir).
The merger combines the two companies’ data sets in order to expedite clinical trials and has the potential to send “shockwaves” through the industry, says ISR president.
Marken has announced an expansion of its third party service providers and customs brokers network to prepare for a “significant’ increase in drug, vaccine, API, and ancillary shipment volumes.
Parexel has announced its financial results for the third quarter of FY16, which remained strong in spite of the complexities associated with smaller clinical trials.
As the company tries to move out from under Shkreli's cloud, KaloBios has announced a new product pricing model that promises transparency, affordably, and reasonable return.
Quintiles and IMS Health have merged to form Quintiles IMS Holdings, effectively creating one of the world’s largest healthcare information portfolios.
Next week, sponsors and CROs will gather in Princeton, New Jersey to discuss how integrating quality, innovation and collaboration can transform the clinical trial process, bringing medicines to patients in a more expedited manner.
Increased use of generics has put pressure on drug reviewers according to the EDQM which has called for more cross border collaboration and harmonization of regulations.
The WHO has accused Semler Research of data fraud and said Mylan, Micro Labs, Lupin and Strides and others may need to repeat bioanalytical trials conducted by the CRO.
Brexit would create regulatory uncertainty, delay the launch of biosimilars and prevent NHS cost savings according to the newly founded British Biosimilars Association (BBA).
Exco InTouch has formed a strategic partnership with Regulatory Strategies, a data protection and compliance consultancy, in response to upcoming reforms.
