The CRO market in Asia has “massive implications” as it continues to emerge as a preferred destination for clinical trials – a global market expected to reach $57bn by 2020.
The renewed contract covers a range of research related services, including monitoring therapeutic trials, prevention trials, and vaccines work, with the ultimate goal of an "AIDS-free generation."
The Trump administration is looking to massively reduce regulations – which could have major implications for pending guidelines that look to increase clinical trial patient safety.
Pharmaron has acquired a majority stake in Shin Nippon Biomedical Laboratories Clinical Pharmacology Center, continuing its strategy of becoming a full service R&D service provider.
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.
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.
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.
The US Food & Drug Administration (FDA) has tasked Icon plc to validate three patient-reported outcomes (PRO) instruments in antibacterial drug trials.
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.
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.
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.
The Association of Clinical Research Professionals (ACRP) has published a new guidance addressing the standardization of competence required for clinical trial monitors.
Researchers need to design more translationally relevant animal studies to improve the potential for success in human clinical trials, according a recent report.
BriaCell Therapeutics Corp. has submitted a chemistry, manufacturing and control (CMC) amendment to the US FDA before its planned stem-cell based vaccine trial for late stage breast cancer.
IntelGenx Corp. and Tetra Bio-Pharma Inc. have signed a binding term sheet for the development and commercialization of a drug product containing dronabinol.
This year, DCAT Week ’17 attendees can expect several new additions to the industry event as it gathers at its new location next month in New York City.
Quotient Clinical has acquired SeaView Research – with another US acquisition to be announced next week, as the company looks to expand its US footprint.
Unconfirmed reports suggest Laboratory Corporation of America Holdings (LabCorp) is in talks to acquire contract research organization Pharmaceutical Product Development LLC (PPD).
Outsourcing companies are expected to witness “significant investments” from private equity and venture capital, despite decreasing investment in the overall healthcare industry.
Chiltern has opened a new process and technology center in Bangalore, India to further support its analytics, risk-based optimization, biometrics, and pharmacovigilance capabilities.
InDex Pharmaceuticals Holding AB has upgraded a deal with Parexel for its Phase IIb trial in Europe for ulcerative colitis, cancelling plans for US centres due to expense.
Parexel’s expanded Managed Access Program helps biopharmaceutical companies provide compassionate access to patients as the industry faces an increasing public demand for treatment options.
Mithra Pharmaceuticals SA will seek US and EU approval for a rival to the NuvaRing contraceptive device in Q2, manufacturing the ring through its independent CDMO platform.
Quintiles, Parexel and Icon are likely to report declining bookings growth in their upcoming financials, says a Jefferies’ analyst, but mid-sized CROs should fare much better.
ICH is currently seeking public comment on proposed "modernizations" to the clinical trial design, planning, management, and conduct guidelines ICH E8 and E6.
