Diteba has developed a novel in vitro approach that allows sponsors to avoid in vivo bioequivalence studies in accordance with a recently released FDA draft guidance.
Proposed legislation would enable contract research organizations (CRO) to claim an R&D tax credit – increasing incentive to conduct clinical trials in the US.
Sandoz and Aurobindo are among drugmakers which will need to provide alternative bioequivalence data after the EMA recommended suspension of medicines tested by Micro Therapeutic Research Labs.
Richmond Pharmacology has opened up a third Phase I research centre in London Bridge, taking over the former Drug Research Unit at Guy’s teaching Hospital.
Genesis Biotechnology Group (GBG) has acquired the preclinical CRO PharmOptima in order to provide customers with a single point-of-contact throughout their drug development programs.
Premier Research has selected ERT’s Trial Oversight suite as its clinical trial management solution to augment sponsor collaboration and help mitigate risk.
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.
The US Food & Drug Administration (FDA) has tasked Icon plc to validate three patient-reported outcomes (PRO) instruments in antibacterial drug trials.
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.
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.
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.
The Chapel Hill, NC-based contract research organization (CRO) has implemented PhlexEview4 as its preferred eTMF solution to support commercial and government clients.
Parexel’s restructuring plan to ‘simplify the organization’ will include eliminating an undisclosed amount of positions as the CRO looks to save on costs.
Pharmaron’s acquisition of Xceleron further supports early discovery, preclinical and clinical development with expanded radiolabeled sciences capabilities.
Worldwide Clinical Trials will support the full scope of Renova Therapeutics Phase III trial for its lead gene therapy product candidate, says the CRO.
Turnover in the US for clinical monitoring jobs at contract research organizations (CROs) has remained high despite efforts to increase salaries, according to a recent report.
Almac Clinical Technologies, part of the Almac Group, has announced a collaboration with Exostar to help mitigate risk associated with intellectual property.
Earlier this week, INC Research announced its intent to expand at its headquarters in Wake County, creating 550 jobs over the next several years as part of a $37.9m investment.
Almac Clinical Technologies, part of the Almac Group, has announced a strategic partnership with the contract research organization (CRO) inVentiv Health.
Wearable technology has been making inroads in the clinical trial industry, however several challenges and concerns surrounding lack of experience still stand in the way of increased adoption.
Cel-Sci has responded to the partial clinical hold imposed on a Phase III trial of its candidate head and neck cancer cell therapy Multikine in September.
CiToxLAB has acquired AccelLAB, a preclinical medical device contract research organization (CRO) as the industry works to align the development of new drugs and medical devices.
CSSi LifeSciences has launched its fully integrated medical device contract research organization (CRO) as an alternative to “traditional ‘big-box’ CROs.”
Cel-Sci has received written confirmation the US FDA has placed a late stage trial of its cancer cell therapy Multikine on partial clinical hold a month after agency first raised concerns.
With a tax incentive program making clinical trials up to 60% more cost-effective, Australia is a “gateway” to larger studies throughout Asia, says CRO.
ATCC has signed a strategic agreement with the contract research organization (CRO) BioAgilytix as part of its ongoing initiative to provide CRO services.
PPD has added 4,300 square feet of new laboratory space for analytical testing of biopharmaceuticals and inhalation devices to the company’s Athlone, Ireland-based GMP facility.
The Society for Clinical Research Sites recently awarded QuintilesIMS with the 2016 Eagle Award, which recognizes contract research organizations (CRO) and sponsors focusing on site relationships.
Premier Research has become the most recent contract research organization (CRO) to receive funding from private equity as the industry looks for "like-minded" partners for the long run.
IMARC Research, an Ohio-based contract research organization (CRO), has expanded its footprint in the medical device market with a new office in Minneapolis, MN.