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Headlines > Clinical Development

Veeva's Vault SiteExchange aims to simplify clinical trial document exchange

20-Apr-2017 - TransCelerate has chosen the Veeva Vault SiteExchange to simplify investigative site collaboration as part of its Shared Investigator Platform Initiative.

Caligor supporting Puma's expanded access program for breast cancer therapy

20-Apr-2017 - Caligor Opco LLC is providing regulatory and logistical management for Puma Biotechnology’s expanded access program (EAP) for its investigational breast cancer therapy, neratinib.

How to accelerate clinical trials during an epidemic

20-Apr-2017 - Randomized controlled trials are the fastest way to identify vaccines in an outbreak, but more collaboration is needed among international researchers – including CROs.

update

CRO Novotech signs MOU with South Korean medical center

18-Apr-2017 - Novotech will conduct clinical trials at the 2,700-bed center with support from the medical’s center staff.

Clinical trial study design: 'one size does not fit all'

18-Apr-2017 - The rate of false positives in clinical trials should be set higher for certain hard-to-treat cancers, suggest researchers.

Inoviem Scientific raises €750k, increasing lab space five-fold

18-Apr-2017 - The Contract Research Biotech (CRB) is broadening its service range as it looks to secure additional long-term deals, says CFO.

Guest article

Medical device CROs: the next growth opportunity?

17-Apr-2017 - Medical device clinical trials have increased 63% since 2012 and a market void for mid-size device CROs could present a significant opportunity for growth.

Verily unveils 'Study Watch' for clinical research

14-Apr-2017 - Verily has unveiled its Study Watch – an investigational device that captures clinical study data for an "unobtrusive trial experience," says CTO.

TrialScope solution reduces clinical trial disclosure non-compliance risks, costs

13-Apr-2017 - ATLAS Global Compliance is a Software-as-a-Service (SaaS) solution that helps clinical trial sponsors to “disclose locally and comply globally,” says TrialScope CEO.

update

Biomedical Systems partners with RadMD to enhance imaging capabilities

12-Apr-2017 - Biomedical Systems has announced a strategic partnership with RadMD through which the companies will collaborate on clinical trials and augment their imaging capabilities.

YPrime aims to simplify clinical trial endpoint collection, support 'BYOD'

12-Apr-2017 - YPrime has released an electronic clinical outcome assessment (eCOA) technology platform to support sponsors, sites, and patients.

Charles River partnership goes beyond traditional FFS model, says Nimbus

12-Apr-2017 - Charles River Laboratories and Nimbus Therapeutics have entered a multi-year strategic partnership to advance programs from early hit identification through Investigational New Drug (IND) submission.

Theradex tapped as CRO for Ph I/II AML trial

11-Apr-2017 - Moleculin Biotech has hired Theradex for its upcoming Phase I/II clinical trial for its lead candidate, Annamycin.

inVentiv, Median strategic alliance brings biomarker imaging to clinical trials

11-Apr-2017 - Median Technologies will provide inVentiv Health clients with various integrated imaging services to support clients at all stages of development.

CRO Accelovance launches oncology-focused initiative

11-Apr-2017 - Accelovance has launched a global initiative dedicated to advancing early phase oncology therapies – an “underserved focus of CROs,” it says.

Providers consolidate as VWR acquires MESM

11-Apr-2017 - VWR has acquired MESM in order to provide customers with end-to-end product and supply chain solutions.

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. 

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