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Headlines > Clinical Development

Where’s the Brexit? UK clinical research industry charts path ahead of EU withdrawal

10-Apr-2017 - Industry leaders gathered at an Emergency Summit Meeting to discuss the implications of Brexit and the future of clinical research in the UK.

PMG automating site work with Devana tech

10-Apr-2017 - PMG Research will use Devana Solutions cloud-based technology across its clinical research facility network.

Legislation would enable CROs to claim R&D tax credit

06-Apr-2017 - Proposed legislation would enable contract research organizations (CRO) to claim an R&D tax credit – increasing incentive to conduct clinical trials in the US.

Novel in vitro approach bypasses in vivo bioequivalence studies

06-Apr-2017 - 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vitro approach that allows sponsors to avoid in vivo bioequivalence studies in accordance with a recently released FDA draft guidance.

Parexel: wearable data collection creates sponsor efficiencies

04-Apr-2017 - Parexel’s new patient sensor solution aims to capitalize on remote clinical trial data collected via medical devices.

WCCT expands clinical research services

04-Apr-2017 - The global contract research organization (CRO) has announced an expanded clinical research service offering after merging with Medelis last year.

Q&A

EMA technical group to address clinical report anonymization

03-Apr-2017 - The EMA has launched a technical anonymization group (TAG) that will help it develop best practices for clinical report anonymization following recent policy changes.

update - US FDA declines to comment on potential investigation

EMA says CRO monitoring activity not location based

30-Mar-2017 - The EMA has stressed its monitoring of CROs is location independent after raising concerns about third Indian contractor in two years.

People on the move

Outsourcing-Pharma’s Hiring and Firing Roundup March ‘17

29-Mar-2017 - Outsourcing-Pharma.com presents this month’s roundup of who is moving where in the contract research and manufacturing industry. 

Bracket: PE investment to support growth, innovation

29-Mar-2017 - The private equity firm, Genstar capital, has acquired the clinical trial technology and specialty services provider, Bracket.

INC Research supporting LLS master trial with Medidata

28-Mar-2017 - INC Research and Medidata are among those supporting the Leukemia & Lymphoma Society’s (LLS) novel, multi-arm clinical trial for acute myeloid leukemia (AML).

Single IRB model will 'dramatically accelerate' treatment delivery, says NIH

28-Mar-2017 - The National Institutes of Health (NIH) has reached a milestone in its goal of accelerating multisite clinical studies through a single institutional review board (IRB) model.

EMA looks to suspend 331 drugs due to ‘misrepresentation of study data’ at Indian CRO

27-Mar-2017 - 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.

Icertis: clinical trial agreement solution reduces contract timelines

27-Mar-2017 - Icertis had upgraded its Clinical Trial Agreement and Budgeting solution – which the company says can reduce contract cycle times by up to 80%.

update

PPD launches CRA apprenticeship program

23-Mar-2017 - PPD is offering "on-the-job" training through a new, competency-based clinical research associate (CRA) apprenticeship program.

Axim taps CRO for cannabinoid product development and clinical trials

23-Mar-2017 - Axim Biotech has contracted an ophthalmology CRO to support upcoming product development and clinical trials for its cannabinoid-based therapeutics.

DCAT WEEK '17

Alcami launches new customer portal and mobile app

22-Mar-2017 - Alcami has launched a new customer portal and mobile application as part of its strategy to further diversify the company.

CROs form strategic alliance to provide end-to-end services

20-Mar-2017 - The strategic alliance between Metrion and Concept will provide clients with a fully integrated ion channel drug discovery service.

Fred Hutch to use Origin Sciences' OriCol in Ph I HIV study

16-Mar-2017 - Fred Hutchinson Cancer Research Center will use Origin Sciences’ novel mucosal sampling device, OriCol, for sample collection as part of a Phase I HIV study.

CRF Health: eConsent adoption to reach 82% by 2020

16-Mar-2017 - The industry can't be slow to adopt eConsent solutions as technology has become an integral part of modern clinical trials, says CRF Health. 

Celerion adds biometric fingerprint tech across units

15-Mar-2017 - Celerion has implemented Verified Clinical Trials’ (VCT) biometric fingerprint technology to address “significant amount” of participants dual enrolling at Ph I units.

SRI secures $90m BARDA contract

13-Mar-2017 - SRI International will advance compounds with the potential to treat persons exposed to biological, radiation, nuclear, and chemical agents – in a deal worth up to $90m.

SGS to operate Ph I inpatient clinical trials at Budapest hospital

09-Mar-2017 - SGS has signed a partnership agreement under which it will operate a dedicated clinical pharmacology unit for conducting Ph I inpatient clinical trials in Budapest, Hungary.

Almac selected as preferred partner for EORTC clinical trials

08-Mar-2017 - Almac Diagnostics will initiate sample profiling on current EORTC trials to further biomarker discovery and development.

CRO-less trial of malaria generic uses crowdfunding to treat bowel cancer

08-Mar-2017 - In the absence of a CRO, the 200 patient NeoART study is relying on the UK NHS, crowdfunding and charity to trial an antimalarial generic for late stage bowel cancer.

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