Data management

CRO SynteractHCR recognized by Swiss for clinical training program

22-Jul-2014 By Zachary Brennan

A Swiss association has recognized the European Centre for Clinical Research Training (ECCRT), a SynteractHCR company, for training investigators and sub-investigators on GCP (good clinical practice).  

Update

Theorem pushes further into India as regulatory hurdles mount

16-Jul-2014 By Zachary Brennan

CRO Theorem Clinical Research and Excel Life Sciences have formed a strategic relationship to bolster Theorem’s clinical development offerings in India just as regulations begin to shift on the subcontinent.

ACRO offers new ways to keep US research competitive

14-Jul-2014 By Zachary Brennan

The Association of Clinical Research Organizations (ACRO) offered a number of recommendations to the US House Energy and Commerce Committee’s “21st Century Cures” initiative last week as part of an effort to keep the US research industry competitive globally.

EMA delays policy on clinical trial data transparency

10-Jul-2014 By Zachary Brennan

The Management Board of the EMA (European Medicines Agency) has postponed the formal adoption of its policy on publication of clinical trial data, though the agency stopped short of revealing exactly why. 

Declaration of Helsinki revisions weaken patient protections, researchers say

08-Jul-2014 By Zachary Brennan

The latest draft revisions of the Declaration of Helsinki (DoH) weaken protections for trial participants in low and middle income countries, Rafael Dal-Ré, director of clinical research at Universidad Autónoma de Madrid, and other researchers argue.

CRO research roundup: Partnership, grant and milestone

07-Jul-2014 By Zachary Brennan

Contract research organizations have seen a number of recent partnerships, grants and milestone payments. Here’s a quick round up of recent deals:

Parexel taps Middle East, North Africa with Atlas acquisition

02-Jul-2014 By Zachary Brennan

CRO Parexel has shifted its attention overseas with the acquisition of Atlas Medical Services, a provider of clinical research services in Turkey, the Middle East, and North Africa. 

Trial documents: only 13% of firms are fully paperless, says Veeva

01-Jul-2014 By Fiona Barry

Contract research organisations (CROs) have been slow to adopt next-generation means of recording study documents, with only 13% using the most up-to-date technologies, according to cloud-based services company Veeva.

Covance launches marketplace to connect biotech, big pharma clients

30-Jun-2014 By Zachary Brennan

Covance has launched a new tool that seeks to connect its emerging biotech clients with established pharma clients via a secure forum.

Dispatches from DIA

Pfizer offers update on risk-sharing deals with Icon, Parexel

30-Jun-2014 By Zachary Brennan

Three years after Pfizer began strategic partnerships with CROs Icon and Parexel, and the companies are still ironing out differences and tweaking their relationships, Mark Sanders, senior director of global sourcing, told attendees at DIA’s annual conference.

Dispatches from BIO 2014

Small biotech experts offer cautious approach to CRO use

26-Jun-2014 By Zachary Brennan

Small biotechs thinking of outsourcing should carefully weigh up the pros and cons say industry experts, who warn that for firms that do contract out clinical development choosing the right CRO is vital.

Dispatches from DIA

Parexel sees calming year after ‘hyper’ growth, CEO says

18-Jun-2014 By Zachary Brennan

A year after CRO Parexel saw what its CEO called “hyper growth,” the Massachusetts-based company is seeing revenue gains return to relatively normal levels.

Dispatches from DIA 2014

BioClinica taps risk-based monitoring with Blueprint Clinical acquisition

17-Jun-2014 By Zachary Brennan

CRO BioClinica will acquire Blueprint Clinical, which offers a cloud-based site scoring tool to help pharma address risk-based monitoring strategies for trials.

Phase II, III research to see bulk of increases in outsourcing, survey finds

16-Jun-2014 By Zachary Brennan

Phase II and III research is expected to see the biggest upturn in terms of outsourcing from large and medium-sized pharma, according to a survey from the Life Sciences Strategy Group.

B-MS pushes back into India with five-year CRO extension deal

05-Jun-2014 By Zachary Brennan

Bristol-Myers Squibb (B-MS) announced a five-year extension to its drug discovery and development collaboration in the subcontinent with Syngene International, India's largest CRO.

iPad tool ‘can replace neuropsychologists’ in cognitive studies

04-Jun-2014 By Fiona BARRY

A UK software maker has launched an iPad tool it says ends the need for CROs (clinical research organisations) to hire trained neuropsychologists to measure drugs’ effects on the brain.

Update

Covance CEO predicts 70% of trials industry will be outsourced

04-Jun-2014 By Zachary Brennan

As biotech funding saw one of the strongest quarters since 2004, Covance CEO Joe Herring predicts that the CRO industry is poised see an even higher percentage of biopharma R&D to be outsourced. 

Veeva aims to boost efficiency with cloud-based data alignment tool

02-Jun-2014 By Anthony King

Veeva Systems says its new global alignment solution for pharmaceutical companies will bring together data interactions and content into its Commercial Cloud.

INC Research signs partnership with Society for Clinical Research Sites

29-May-2014 By Zachary Brennan

CRO INC Research has inked a two-year partnership with the Society for Clinical Research Sites (SCRS) to become a more active voice in the site investigator community.

Payment automator Clinverse partners with eClinical Insights

29-May-2014 By Zachary Brennan

Clinverse, a company which automates the financial lifecycle of global clinical trial providers, and eClinical Insights, a provider of cloud-based clinical trials software, have formed a strategic partnership to offer an integrated tool for clients.

Targos, Wuxi to collaborate on biomarker services, pathology training in China

28-May-2014 By Zachary Brennan

Clinical biomarker service company Targos is partnering with Wuxi PharmaTech to provide know-how, services, and quality standards to support Wuxi's bioanalytical work for biopharma customers.

TransCelerate partners with Medidata to focus on risk-based monitoring

22-May-2014 By Zachary Brennan

Medidata will provide metrics and analytics help to industry group TransCelerate to answer questions on the benefits and challenges associated with a risk-based approach to monitoring of clinical trial sites.

BioOutsource offers inside look at new biosimilar draft guideline

21-May-2014 By Zachary Brennan

Outsourcing-Pharma.com reached out to contract testing supplier BioOutsource to see what its take is on biosimilars now that the FDA’s draft guidance on biosimilarity has been released. The following is a lightly edited interview with BioOutsource’s chief...

Dispatches from the Biological Production Forum

Valeant puts head in the Cloud to manage over 800 CMOs

13-May-2014 By Dan Stanton

Managing over 800 CMOs could lead to quality and compliance nightmares but Valeant says it has come up with a unique cloud-based strategy. 

Quintiles pushes into EHR services with Encore purchase

13-May-2014 By Zachary Brennan

CRO Quintiles on Monday announced that it has signed an agreement to acquire Encore Health Resources, which offers health-information analytics and electronic health record (EHR) services.  

China's Tigermed acquires $50m majority stake in Frontage Labs

12-May-2014

Chinese CRO Tigermed has entered a definitive agreement to acquire a majority stake in the ownership of CRO Frontage Laboratories for $50.25m in cash, some of which the company will use to expand clinical capacity in New Jersey.

CROs more than sponsors turning to QbD for clinical research, survey finds

09-May-2014 By Zachary Brennan

CROs (contract research organizations) are more likely than sponsors to report frequent application of QbD (quality by design) principles for clinical research, though neither group seems particularly comfortable with QbD yet, according to preliminary...

CROs to 'push' patients into trials using partners, report predicts

14-Apr-2014 By Dan Stanton

Patient recruitment is “the major bottleneck” in clinical development, an Industry Standard Research report says, but though it predicts a drive to ‘push’ patients into trials, industry disagrees.

Alliance with patient network won't replace CRO partnerships, says Genentech

09-Apr-2014 By Dan Stanton

Genentech says its collaboration with PatientsLikeMe will enable more effective clinical trial recruitment but will not affect its partnerships with CROs.

BioClinica inks $30m in contract extensions with two top pharmas

02-Apr-2014 By Zachary Brennan

CRO BioClinica has signed two multi-year contract extensions worth $30m for cloud-based technologies and professional services and training across its e-clinical product suite.

Drugmakers start your engines: GSK's Formula One discovery formula

26-Mar-2014 By Gareth Macdonald

GSK has asked Formula One team Mclaren to help it discover drugs, arguing that Big Data expertise from outside the contract research sector can accelerate its efforts to develop new blockbuster meds.

Parexel joins cloud-based community of life science companies

13-Mar-2014 By Zachary Brennan

Cloud-based community provider Exostar has selected Parexel as the latest CRO to become a member of its life science community, which aims to reduce the cost and burdens of collaborations between companies.

UDG adds EU and US firm to its communication service division

03-Mar-2014 By Dan Stanton

UDG Healthcare has expanded its position in the pharma communications industry with the $144m (€105m) acquisition of KnowledgePoint360.

WCCT offers 'In-Site' to patient recruitment, through new platform

18-Feb-2014 By Dan Stanton

WCCT Global has launched a patient recruitment platform it says speeds up recruitment time and can cut sponsor costs with a more targeted advertising campaign.

Theorem, Decision Driver form strategic alliance

12-Feb-2014 By Zachary Brennan

Theorem Clinical Research has announced the formation of a strategic alliance with Decision Driver Analytics (DDA) to integrate health economics and outcomes research, predictive modeling and definitive analysis to maximize return on investment for pharmaceutical...

IOM looks into new ways to share clinical trial data

30-Jan-2014 By Zachary Brennan

The Institute of Medicine is conducting a consensus study to recommend guiding principles and a framework for the responsible sharing of clinical trial data before a final report is released in December 2014.

Novo Nordisk partners e-recruitment firm to boost diabetes trial numbers

22-Jan-2014 By Dan Stanton

Novo Nordisk has selected patient recruitment firm Trialbee to boost participant numbers in diabetes studies using its web-based platform.

Dispatches from PCT

Quintiles is the "arms, legs and brain" in Merck Serono's monogamous relationship

02-Dec-2013 By Dan Stanton

Trust, transparency and end-to-end participation are just some of the reasons Merck Serono says its exclusive strategic partnership with Quintiles is the “first of its kind.”

Dispatches from PCT

Pfizer: Active role for patients as smartphones lead way in virtual trials

25-Nov-2013 By Dan Stanton

Smartphones are changing the role of the patient in clinical trials and can be used for industry success, Pfizer and technology provider firm Exco InTouch said at PCT 2013.

CROs turn to app platform to speed development of CTMS modules

07-Nov-2013 By Zachary Brennan

Plagued with tighter deadlines and calls for more efficiency, CROs (contract research organizations) seem to be increasingly turning to apps and cloud-based systems to develop CTMS (clinical trial management system) modules.

Some specialty CROs seeing early phase research revival

05-Nov-2013 By Zachary Brennan

After almost two years of lagging early phase clinical research work, it seems some CROs are now seeing an uptick in specialized trials that require more scientific expertise.

inVentiv takes a stranglehold on the patient adherence market with acquisition

04-Nov-2013 By Zachary Brennan

Pharma service provider inVentiv Health has acquired Catalina Health and is merging it with its subsidiary Adheris to create the largest direct-to-patient adherence program in the US. 

Parexel shares down as concerns over low bookings remain

04-Nov-2013 By Zachary Brennan

CRO Parexel’s stock fell to a four-month low and continued to hover around that level late last week following concerns about low bookings and increased competition in the first quarter of 2014.

Dispatches from CPhI

McKinsey consultants help to pull Patheon off the road to bankruptcy

23-Oct-2013 By Zachary Brennan

Patheon brought in McKinsey consultants over the last three years to help overhaul its sagging business and institute a number of simple process changes that resulted in deep transformations.

DrugDev acquires site payment specialist CFS Clinical

22-Oct-2013 By Zachary Brennan

Sponsor network developer DrugDev on Monday announced it would acquire CFS Clinical, which specializes in managing the financing of clinical trials.  Financial terms were not disclosed.

Parexel strikes another eClinical deal in Asia

15-Oct-2013

Parexel has teamed up with Japanese trial management services firm Fuijitsu Systems West in an agreement that underlines the CROs eClinical growth ambitions in Asia.

Cmed to open offices to service East and West Coast clients

14-Oct-2013 By Dan Stanton

The Cmed Group has realigned its US operations with two new offices planned to suit the geographical needs of its clients.

Quintiles calls for voluntary, non-public release of masked clinical trial data

08-Oct-2013 By Zachary Brennan

CRO Quintiles says it is in favor of the voluntary sharing of de-identified and masked clinical and preclinical data that protects the interests of research participants and proprietary data, though it stopped short of calling for the public release of...

Covance looks to cut external lab testing costs by 65% with new offering

07-Oct-2013 By Zachary Brennan

CRO Covance has launched an external laboratory management service offering for biopharmaceutical sponsors looking to external lab testing for its clinical trials.

CMO hit with first ever US FDA warning letter for failing to pay facility fee

03-Oct-2013

Germany-based CMO CPM Contract Pharma was hit with the first US FDA warning letter for failing to self-identify its manufacturing facility and pay the facility fee required by the Generic Drug User Fee Amendments of 2012.