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Headlines > Clinical Development

Gene therapy no longer science fiction: IRB launches biosafety committee service

02-May-2017 - Schulman IRB has launched a new service to ensure sponsors, CROs, and others are compliant when conducting genetic engineering research – “given the diverse risks,” says committee lead.

PPD valued at more than $9bn as investors recapitalize

01-May-2017 - A new ownership structure at Pharmaceutical Product Development, LLC (PPD) is designed to help drive the company’s next phase of growth.

QuintilesIMS, Salesforce launch multi-year venture

01-May-2017 - QuintilesIMS has announced an alliance with Salesforce through which the companies aim to “equip and enable” customers to meet future healthcare challenges.

Bracket initiates BYOD ePRO study in Japan

26-Apr-2017 - Bracket has launched a Bring Your Own Device (BYOD) electronic patient-reported outcome (ePRO) Ph III study in Japan.

Covance plans closures – and expansions – as it aims to 'right-size'

26-Apr-2017 - LabCorp’s Covance is implementing a two-phase plan intended to create operational efficiencies over the next three years.

Covance ups BioPharmCMC capabilities in UK

25-Apr-2017 - Covance is expanding into new laboratories in York, England as it anticipates continued growth into 2018.

Siteless CRO drafts guidelines for 'modern clinical trial'

25-Apr-2017 - Center Point Clinical Services has released new guidelines that look to address clinical trial challenges by focusing on the patient, not the CRO.

CRO tapped for Evoke comparative exposure PK trial

25-Apr-2017 - Spaulding Clinical Research will conduct Evoke Pharma’s planned comparative exposure pharmacokinetic (PK) trial for its lead product candidate, Gimoti.

Certara launches CDISC PK solution

24-Apr-2017 - Certara has launched a new solution for preparing, analyzing, and submitting pharmacokinetic (PK) data in Clinical Data Interchange Standards Consortium (CDISC) format.

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.

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