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Headlines > Clinical Development

Dispatches from PCT US

TransCelerate CEO, leaders offer update on industry group’s activities

27-Apr-2015 - As 20 of the largest biopharma companies have now joined industry group TransCelerate, the group is beginning to use patient centricity and connectivity to influence the clinical trial environment, CEO...

Dispatches from PCT US

Experts discuss the impact of M&A on CRO, sponsor partnerships

24-Apr-2015 - As M&A continues to ramp up for the pharma and biotech industry, communication and agility are two of the major keys for CROs to adapt to an acquisition, experts said...

Dispatches from PCT US

All about that base: Risk-based monitoring takes center stage

23-Apr-2015 - As sponsors and CROs continue the inevitable shift away from 100% SDV (source data verification) in line with US FDA and TransCelerate guidance, new risk-based monitoring (RBM) strategies are cropping...

Pfizer reveals PPD as third strategic CRO partner

22-Apr-2015 - Pfizer has selected PPD as its third preferred contract research organisation (CRO), but the addition will not affect ongoing relationships with Parexel and Icon, the firm says.

Update

US FDA to accept foreign trial data for approving medical devices

21-Apr-2015 - The FDA is releasing draft guidance articulating its current policy of accepting valid clinical data obtained from foreign clinical studies in support of premarket submissions for medical devices. 

INC joins with SCRS to create site advocacy group on investigator payments

20-Apr-2015 - Cash-strapped investigator sites seeking new ways to ensure they get paid promptly will find some new forms of relief in a recently formed Site Advocacy Group (SAG) created by INC...

WCG calls on 1200 member institutions to adopt Accelerated Clinical Trial Agreement

20-Apr-2015 - As part of efforts to reduce clinical trial start-up times, WIRB-Copernicus Group (WCG), the world's largest provider of regulatory and ethical review services for human research, said it will encourage...

News in brief

PRA Health Sciences to add 87 new jobs to Welsh site

20-Apr-2015 - North Carolina-based CRO PRA Health Sciences (PRA) is expanding its business in Swansea, Wales, with the creation of 87 new jobs. 

Sartorius adds biologics testing through acquisition of CRO BioOutsource

17-Apr-2015 - Sartorius has expanded its biopharma services to include contract testing by buying CRO BioOutsource.

Who's going places in the outsourcing world?

17-Apr-2015 - A number of outsourcing companies are shifting and adding to their executive decks. Here's a roundup of a couple new moves:

Ocular CROs ally to meet demand for global clinical trials

17-Apr-2015 - EU-based Iris Pharma, an ophthalmology-focused CRO (contract research organization) and US-based Oculos Clinical Research, a full-service CRO, announced Thursday a strategic alliance that aims to help sponsors conduct more global...

Quintiles pushes further into LatAm with Argentinian hospital alliance

17-Apr-2015 - Quintiles on Thursday announced the selection of Hospital Italiano of Buenos Aires, Argentina, as the company’s first “Prime Site” in Latin America, adding to the company’s network of investigative sites...

WuXi offers more details on the complexity of CRO, CMO competition

15-Apr-2015 - Competition in the notoriously tight-lipped CRO (contract research organization) and CMO (contract manufacturing organization) industries is getting fiercer as outsourcing picks up, though that hasn’t stopped one Chinese company from...

Russia sees slight dip in clinical trial approvals in Q1 2015

15-Apr-2015 - The Ministry of Health of the Russian Federation approved 151 total clinical studies in Q1 of 2015, which is 11% less than the same quarter last year, though by comparison,...

WHO: incentives and enforcement needed to improve trial data transparency

15-Apr-2015 - Publishing summary clinical trial results poses no threat to patient privacy according to the WHO, which says enforcing transparency laws and incentivising sponsors is key to making sure data from...

News in brief

Parexel’s QSI acquisition: An opportunity for pharmacovigilance

14-Apr-2015 - With the closing of the acquisition of QSI (Quantum Solutions India), Parexel is looking to help serve its clients further in the pharmacovigilance space.

Quintiles, Parexel, PPD lead all CROs in US trial totals, review finds

14-Apr-2015 - CROs (contract research organizations) continue to collaborate with sponsors on more clinical trials in the US, though the largest companies, such as Quintiles, Parexel and PPD, are working on a...

WHO says anything short of full trial disclosure skews public spending

14-Apr-2015 - Drug, vaccine and medical device developers should publish all trial results according to the WHO, which says anything less skews R&D priorities and public healthcare investment.

CRO Clinipace expands Euro footprint with acquisition of Accovion

13-Apr-2015 - With an eye for a stronger presence in Europe, CRO Clinipace has merged with Accovion, Frankfurt, Germany-based full-service CRO.

Update

TransCelerate launches two new initiatives to accelerate clinical trials

10-Apr-2015 - Industry group TransCelerate BioPharma has established two new global initiatives around placebo and standard of care data sharing, and electronic labels for clinical trials – both of which aim to...

Lower-cost Latin American market to drive growth for CROs, Frost report finds

08-Apr-2015 - A new Frost & Sullivan report predicts the Latin American clinical research market for CROs (contract research organizations) will grow at a pace of 7.1% through 2019, with larger CROs...

PPD completes JV to push further into Japanese clinical development services

08-Apr-2015 - Wilmington, North Carolina-based CRO (contract research organization) PPD (Pharmaceutical Product Development) and Tokyo-based Shin Nippon Biomedical Laboratories (SNBL) have closed an agreement to form a joint venture to provide clinical development services in...

'Unjustified' ban of GVK-tested drugs has damaged India, says Pharmexcil

08-Apr-2015 - The reputation of Indian clinical trials has been damaged by the “unjustified” suspension of medicines tested by GVK Biosciences, Pharmexcil says as it attacks the evidence submitted by French regulators.

UK, Australia, Canada offer CROs R&D tax credits, E&Y says

03-Apr-2015 - A number of different countries offer tax incentives that generally seek to attract pharma companies conducting research, and often can help CROs (contract research organizations) as well, an Ernst &...

CRO roundup of recent trial wins for LabCorp, inVentiv, Evotec

02-Apr-2015 - LabCorp, as well as its recent acquisition Covance, along with CRO (contract research organization) peers inVentiv and Evotec have all landed small to medium-sized pharmaceutical deals in the past week.

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