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News in brief

QPS tapped for Acticor Biotech FIH study

27-Feb-2017 - Acticor Biotech has contracted QPS to manage a Phase I study of the company’s humanized Antibody Fragment, ACT017.

INC Research expands FSP services

27-Feb-2017 - INC Research has expanded its Functional Service Provider (FSP) service offering to include investigator payment processing in response to increased transparency requirements.

QuintilesIMS eyes revenue growth with refinancing

23-Feb-2017 - QuintilesIMS has announced an offering of senior notes and a proposed debt refinancing as leadership looks to drive revenue growth, according to a Jefferies analyst.

Gov’t delay could postpone usability, patient recruitment

23-Feb-2017 - Several organizations have penned an open letter to NIH urging it adhere to 21st Century Cures deadlines that if missed, will affect improvements to – and ultimately, study start...

PPD collaborating with nephrology expert Frenova

22-Feb-2017 - Pharmaceutical Product Development, LLC (PPD) is expanding its therapeutic expertise through a new collaboration with Frenova Renal Research.

Bioclinica: more stakeholders pushes need for collaboration

22-Feb-2017 - 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 eCOA platform a 'major step forward,' says CEO

22-Feb-2017 - 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.

Icon awarded FDA project to validate PRO instruments

21-Feb-2017 - The US Food & Drug Administration (FDA) has tasked Icon plc to validate three patient-reported outcomes (PRO) instruments in antibacterial drug trials.

Belgian CRO launches EU joint venture with Chromatography Institute

20-Feb-2017 - 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.

EMA: GCP deviations increasing

20-Feb-2017 - The EMA recently updated its Good Clinical Practice (GCP) Q&A to address several contractual arrangement “pitfalls” – specifically with electronic systems vendors.

Clinerion enters Asia through strategic alliance with ASUS Life

20-Feb-2017 - The alliance expands the geographic reach of sponsors, giving customers real-time, EHR-based insight on the Taiwanese patient population.

Strategic CRO takes $100m hit from Pfizer's shelved PCSK9 candidate

17-Feb-2017 - 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.

HPCTC adopts biometric fingerprint tech to register patients

16-Feb-2017 - High Point Clinical Trials Center (HPCTC) has partnered with Verified Clinical Trials to help prevent duplicate enrollment in clinical trials.

Quotient buys QS Pharma in latest US expansion move

15-Feb-2017 - Quotient Clinical Ltd. has bought Charles River Laboratories’ contract manufacturing business, QS Pharma LLC.

Almac Discovery and RCSI enter research collaboration

15-Feb-2017 - 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 and Takeda establish new joint venture in Japan

15-Feb-2017 - PRA Health Sciences and Takeda Pharmaceutical Company are expanding their partnership to Japan as Takeda accelerates the “transformation” of its R&D organization.


ACRP develops framework in response to 'significant' CRA shortage

14-Feb-2017 - The Association of Clinical Research Professionals (ACRP) has published a new guidance addressing the standardization of competence required for clinical trial monitors.

Orgenesis granted €12.3m for GMP production ahead of clinical trials

14-Feb-2017 - Orgenesis’ Belgian subsidiary, Orgenesis SPRL, has received €12.3m ($12.8m) to further develop its Type 1 Diabetes program.

CRO Beaufort certified under ISO 9001:2015

14-Feb-2017 - Beaufort, LLC has completed the multi-stage audit for the certification that it said separates it from other contract research organizations (CROs).

Report: study design flaws slowing Parkinson's research

13-Feb-2017 - Researchers need to design more translationally relevant animal studies to improve the potential for success in human clinical trials, according a recent report.

News in brief

Parexel launches RTSM mobile app

13-Feb-2017 - Parexel has launched a mobile application for its ClinPhone® randomization and trial supply management (RTSM) service.

Pharm-Olam nabs PE investment amid 'market void' for mid-tier CROs

13-Feb-2017 - Pharm-Olam has secured an investment from Quad-C Management as the private equity firm eyes add-on acquisitions to complement organic growth.

BriaCell files CMC amendment and preps for breast cancer vaccine trial

10-Feb-2017 - 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 and Tetra Bio-Pharma developing dronabinol tablet

09-Feb-2017 - IntelGenx Corp. and Tetra Bio-Pharma Inc. have signed a binding term sheet for the development and commercialization of a drug product containing dronabinol.

Kitov CEO questioned over Ph III data concerns

09-Feb-2017 - Kitov Pharmaceuticals Holdings Ltd. is standing by the validity of its Phase III clinical trial data results as investigations begin.

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