Premier Research has selected ERT’s Trial Oversight suite as its clinical trial management solution to augment sponsor collaboration and help mitigate risk.
Approximately 400 clinical trials in a rare disease condition are currently registered on ClinicalTrials.gov – on Rare Disease Day 2017, Outsourcing-Pharma.com examines the numbers.
Researchers and patients have more efficient tools for sharing information on rare diseases, and as knowledge continues to spread, rare disease studies will become less rare.
Titan Pharmaceuticals has put plans for a trial of its candidate Parkinson’s disease implant ropinirole after the US FDA asked for additional information.
GSK has asked Angus Council for advice as it prepares to submit a planning application for an API plant it intends to build at its site in Montrose, Scotland.
The Global Biological Standards Institute (GBSI) has outlined an action plan after finding the frequency of irreproducible preclinical research exceeds 50% – costing the US nearly $28bn.
Pharma Outsourcing & Partnership Global Congress 2017 Europe
INC Research has expanded its Functional Service Provider (FSP) service offering to include investigator payment processing in response to increased transparency requirements.
Several organizations have penned an open letter to NIH urging it adhere to 21st Century Cures deadlines that if missed, will affect improvements to ClinicalTrials.gov – and ultimately, study start up.
Ohr Pharmaceutical Inc. has halted activities at the laboratory in San Diego, California where research on its sustained release delivery technology was carried out.
Dr Reddy’s Laboratories has been issued with a Form 483 after an inspection at its active pharmaceutical ingredient (API) plant in Miryalaguda in Telangana, India.
Dubbed LAB282, the £13m (€15M) Oxford University drug discovery program with Evotec has announced two grant winners and a second set of awards of up to £250,000.
Modus Therapeutics AB has raised an additional 32m SEK (£2.85m) for its Phase II trial for pain crises in Sickle Cell Disease, running in the Caribbean, Middle East and Europe.
Bioclinica has expanded its eHealth App xChange to make a greater range of technologies available to the increasing number of industry stakeholders – many with differing priorities.
iCardiac’s new eCOA platform, QPoint, can measure clinical outcome assessments from patients at home or during site visits and will soon integrate with emerging wearables.
Momenta Pharmaceuticals has reiterated its belief that problems at a US Pfizer plant mean the FDA is unlikely to reach a decision on its 40mg version of Teva’s Copaxone before April.
The US Food & Drug Administration (FDA) has tasked Icon plc to validate three patient-reported outcomes (PRO) instruments in antibacterial drug trials.
The CRO JSS Medical Research will use EnduraData’s cloud tool to synchronize medical research data between servers in Canada and Colombia, South America.
A radiopharmaceuticals plant is the most likely source of the radioactive iodine-131 detected in several countries in recent weeks according to experts.
Granules India will build an API production facility in Bonthapally, Telangana and expand other manufacturing sites in a project backed by the Word Bank.
The EMA recently updated its Good Clinical Practice (GCP) Q&A to address several contractual arrangement “pitfalls” – specifically with electronic systems vendors.
The Research Institute for Chromatography (RIC) and Anacura have joined forces to create anaRIC biologics, an R&D and GMP analytical specialist CRO for biologics.
The US FDA has issued a warning letter to the former Hospira fill and finish facility in McPherson, Kansas – now part of Pfizer’s contract manufacturing business CentreOne.
Medical marijuana developer Tilray has begun shipping to overseas patients and trial sites outside Canada after partnering with local distributors to comply with regional regulations.
Contract research organisation (CRO) ICON has taken a hit to its book-to-bill ratio after Pfizer dropped its anti-cholesterol candidate bococizumab in November.
Charles River Laboratories International Inc. has sold off its CDMO business QS Pharma LLC, saying the small-molecule manufacturing business was “not optimized” within the firm's portfolio.
Medical cannabis supplier Tilray has expanded its formulary team and mooted the idea of extending its distribution network just weeks after the EMA granted its Canadian production site GMP accreditation.
Dr. Reddy’s Laboratories Ltd has said it may invest in additional manufacturing capacity to support its efforts to grow in the European hospital drug market.
End-to end service offerings are a differentiator within the fragmented CMO industry and not driven by pharma demand, a Results Healthcare report says.
Almac Discovery and the Royal College of Surgeons in Ireland (RCSI) and have announced a research collaboration aimed at understanding how to target therapy-resistant cancer tumors.
PRA Health Sciences and Takeda Pharmaceutical Company are expanding their partnership to Japan as Takeda accelerates the “transformation” of its R&D organization.
CMOs will struggle to compete with large in-house capacity investments, according to Results Healthcare which predicts a decline in outsourced biomanufacturing.
