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Headlines > Clinical Development

Worldwide Clinical Trials advancing cannabis-based formulations for human studies

20-Jul-2017 - Worldwide Clinical Trials is developing a pre-IND plan and designing pilot studies for evaluating the effectiveness of GB Sciences’ proprietary cannabis-based therapeutic, says CMSO.

ABL advancing HIV vaccine as part of 7 year, $318m contract

19-Jul-2017 - ABL, Inc. has been awarded a preclinical development support contract to help advance an HIV vaccine and other biologics candidates.

FDA outlines Cures implementation, touts in silico clinical trials

18-Jul-2017 - The US FDA has revealed its work plan  for implementing aspects of the 21st Century Cures Act, including an investment in in silico tools for use in clinical trials....

AI platform nabs $2m to connect patients and providers with clinical trials

18-Jul-2017 - Mendel.ai has raised $2m in seed funding to advance its artificial intelligence engine that connects doctors and patients with clinical trials.

Catalent expands formulation offerings

18-Jul-2017 - Catalent Pharma Solutions has expanded its OptiForm Solution Suite platform from candidate selection through Phase I.

DIA 2017

When, where, and how? Experts examine the current state of Brexit

13-Jul-2017 - The pharmaceutical industry and regulators are preparing for Brexit and how to best “manage and mitigate” any potential risks the UK’s departure from the EU may pose.

Worldwide Clinical Trials taps Medidata for payments solution

12-Jul-2017 - Worldwide Clinical Trials has planned its rollout and risk mitigation strategy as it implements Medidata’s Payments Cloud to automate site payments, says CFO.

Betting on biosimulation: Certara acquired for $850m

11-Jul-2017 - EQT's acquisition of Certara is a bet on the continued convergence of healthcare and technology as the industry further adopts biosimulation to advance drug development.

CRF Health creates electronic forms for MS clinical trials

11-Jul-2017 - CRF Health has developed an electronic implementation of an assessment and documentation tool for Multiple Sclerosis (MS) clinical trials.

Q&A

Cancer in the Asia-Pacific, a CRO perspective

10-Jul-2017 - As cancer rates increase in the Asia-Pacific region, and clinical trial capabilities grow in India and China, demand for research is on the rise.

INC Research expands catalyst program to psychiatric-related trials

07-Jul-2017 - The new network provides member sites with access to dedicated support as psychiatry clinical research becomes more complex, says CRO.

News in brief

PRA to conduct Ph Ib/II clinical trial of PLK1 inhibitor

06-Jul-2017 - Trovagene, Inc. has contracted PRA Health Sciences to conduct its Phase Ib/II clinical trial of PCM-075 in patients with acute myeloid leukemia (AML).

CTTI maps novel endpoints to accelerate mobile tech use in clinical trials

06-Jul-2017 - The Clinical Trials Transformation Initiative (CTTI) has released novel endpoint recommendations to catalyze mobile technology use in clinical trials.

News in brief

WCT selected to conduct Ph III NurOwn Trial in ALS

05-Jul-2017 - BrainStorm Cell Therapeutics has contracted Worldwide Clinical Trials (WCT) to conduct its planned Phase III study of NurOwn in the treatment of amyotrophic lateral sclerosis (ALS).

INC Research continues to expand in Japan

03-Jul-2017 - INC Research has relocated and expanded its Tokyo, Japan-based office to support the company’s growth strategy in the Asia-Pacific region.

People on the move

Outsourcing-Pharma's Hiring and Firing Roundup June '17

29-Jun-2017 - This month’s round up includes a new chief manufacturing officer at Brammer Bio and an executive hire at PPD who will help guide the CRO’s laboratory services.

DIA 2017

CFDA: reform will continue, data forging to be 'severely punished'

28-Jun-2017 - The China Food and Drug Administration (CFDA) has become a member of ICH as it looks to continue advancing regulatory reform to improve the review process.

Continuum partners with social network to crowdsource late-stage clinical trials

28-Jun-2017 - Continuum Clinical has partnered with Skipta to expedite physician and patient participation in clinical trials.

DIA 2017

RBM adoption driving growth as CROS NT evolves service offering

26-Jun-2017 - CROS NT has announced a new clinical trial solution that enables sponsors to take a risk-based approach to site monitoring – a shift to which is driving company growth, says CEO.

Cells held three times as long in 'delayed crosslinking' microgel tech

22-Jun-2017 - Dutch scientists have developed a microgel chip that is capable of holding single cells for analysis and research for far longer than currently available 3D culturing technologies.

Helomics teams with investment firm to launch biotech incubator in Pennsylvania, US

22-Jun-2017 - Helomics Corporation and Pittsburgh Life Sciences Greenhouse (PLSG) have collaborated to form a biotechnology incubator with a precision and diagnostics medicine focus.

Q&A

How to prepare for ICH E6 R2 implementation

22-Jun-2017 - ICH E6 (R2) modernizes the ICH Good Clinical Practice (GCP) Guideline, which was implemented more than 20 years ago.

Guest article

A closer look at the Parexel deal

21-Jun-2017 - Another day, another CRO acquisition – this time Parexel, a top 10 CRO, was acquired by Pamplona Capital, a large private equity firm.

DIA 2017

Deloitte to upgrade Daiichi Sankyo's global drug safety platform

21-Jun-2017 - Daiichi Sankyo has adopted Deloitte’s ConvergeHEALTH Safety platform in order to enhance its global pharmacovigilance capabilities.

Parexel to be acquired by PE in $5bn deal

20-Jun-2017 - Parexel International Corporation has signed a definite agreement to be acquired by the private equity firm Pamplona Capital Management, LLP.

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