Data management

Wuxi manufacturing continues to roll, two new facilities on the way

17-Nov-2014 By Zachary Brennan

With biologics declared as its main driver over the next few years, CDMO Wuxi is seeing rapid manufacturing growth and planning two new facilities in the next two years.

ERT moves into trial management software with eClinical Insights acquisition

11-Nov-2014 By Zachary Brennan

Patient safety and efficacy endpoint data collector ERT has acquired eClinical Insights (eCI), a provider of cloud-based clinical trials management software, for an undisclosed sum.  

China sets new requirements for hospitals running clinical trials

10-Nov-2014 By Zachary Brennan

The Chinese authorities are supplementing their current regulations around clinical trials with new mandates for the hospitals that conduct the studies. 

GVK BIO steps into GLP tox with Vanta Bioscience acquisition

10-Nov-2014 By Zachary Brennan

Indian CRO GVK BIO announced the signing of a definitive agreement to acquire Vanta Bioscience, a full service preclinical GLP toxicology and safety assessment CRO operating out of Chennai, India.

Survey finds CROs far from going paperless with TMFs

30-Oct-2014 By Zachary Brennan

Although the barriers for going paperless are relatively low for CROs, the service providers have yet to fully adopt electronic TMFs (trial master files), a new survey says.

INC Research sets pricing for IPO at $150m

29-Oct-2014 By Zachary Brennan

The Raleigh, North Carolina-based CRO INC Research plans to raise about $150m in its initial public offering via about 8.1m shares at a price range of $17 to $20 per share. 

Strategic partnerships yet to fully catch on, Tufts report finds

29-Oct-2014 By Zachary Brennan

Although a growing number of sponsors and CROs have managed strategic relationships for as many as five years, sponsors still rely on a mix of outsourcing approaches to tackle their clinical programs, according to a new report.

MPI Research pushes further into early phase development with CRO acquisition

28-Oct-2014 By Zachary Brennan

MPI Research announced Monday it has acquired the assets of Kalamazoo, Michigan-based CRO Jasper Clinical Research & Development, which provides early-stage human clinical testing of new drugs for an undisclosed amount.

Forum to help CROs interact with TransCelerate

28-Oct-2014 By Zachary Brennan

The Association of Clinical Research Organizations (ACRO) on Monday announced plans to create a CRO Forum in order to provide a formal mechanism for the CRO industry to offer insight into the work of industry group TransCelerate BioPharma.

WuXi partnership to bring genomic profiling to Chinese clinical trials

27-Oct-2014 By Zachary Brennan

CRO WuXi PharmaTech is collaborating with Foundation Medicine to provide genomic profiling to biopharma companies conducting clinical trials in China.

Parexel pushes further into UK with new grants, Nottingham office

21-Oct-2014 By Zachary Brennan

Little more than a week after purchasing the UK RTSM provider ClinIntel, Parexel has secured new office space in Nottingham, UK and won grants totalling £1m ($1.6m). 

Novartis calls on Covance to help with Big Data

16-Oct-2014 By Gareth Macdonald

Covance’s collection of drug development data is set to get bigger though a collaboration with Swiss drugmaker Novartis.

Thermo Scientific assesses PK/PD analysis tool after study shows bioequivalence data discrepancies

14-Oct-2014 By Dan Stanton

Thermo Scientific is assessing its PK/PD data analysis software after a technical paper found discrepancies in results that may have affected drug approvals.

New EMA trial transparency policy may mean higher legal costs for CROs say campaigners

06-Oct-2014 By Zachary Brennan

The European Medicines Agency (EMA) on Jan. 1 will begin publishing clinical trial reports, which underpin the decision-making on medicines. 

Parexel acquires RTSM service provider ClinIntel

06-Oct-2014 By Zachary Brennan

CRO Parexel International has acquired all of the outstanding equity securities of privately-owned and UK-based ClinIntel, a provider of clinical Randomization and Trial Supply Management (RTSM) services.

WuXi expands testing division in US with acquisition of CRO XenoBiotic Laboratories

02-Oct-2014 By Zachary Brennan

China-based WuXi PharmaTech has acquired CRO XenoBiotic Laboratories (XBL) to bolster its bioanalytical and DMPK (Drug Metabolism and Pharmacokinetics)/ADME (absorption, distribution, metabolism, and excretion) services. Financial terms were not disclosed....

Medidata hit by $4.8m wire fraud, but says customer clinical trial data is safe

29-Sep-2014 By Gareth Macdonald

Fraudsters who hoodwinked Medidata Solutions into transferring $4.8m to an "overseas" account this month did not access customer data says the clinical trial IT firm.

PPD increases stake in small molecule discovery company X-Chem citing Big Pharma relationships

29-Sep-2014 By Zachary Brennan

CRO PPD has exercised its option to acquire the remaining minority ownership interest of X-Chem for an undisclosed sum. X-Chem will continue to operate as a small molecule discovery company with its entire existing staff and management team. 

Update

EMA opens investigation into India’s GVK Bio over ECG falsifications

26-Sep-2014 By Zachary Brennan

At the request of the European Commission, the EMA (European Medicines Agency) announced Friday that it would open a review into findings that GVK Biosciences’ site in Hyderabad, India falsified electrocardiograms in all nine clinical trials evaluated. 

AstraZeneca brings IT services in-house with new Indian facility

25-Sep-2014 By Dan Stanton

The opening of a global IT centre in India will bring services back in-house, but AstraZeneca says it is not changing its outsourcing strategy for R&D and manufacturing.

Researchers highlight why clinical data should be more transparent

25-Sep-2014 By Zachary Brennan

The rarity of medical research reanalysis and the extent to which reanalysis changes the original findings has two physicians calling for more transparency in an editorial in this month’s JAMA (Journal of the American Medical Association).

French regulator raises concerns over Indian CRO studies

25-Sep-2014 By Zachary Brennan

Concerns over India-based GVK Biosciences have been raised in a letter from France’s ANSM (Agency for Medicines and Health Products Safety) to marketing authorization holders following a GCP (good clinical practice) inspection citing deficiencies in the...

Covance, Frenova team to share and analyze data on CKD, renal disease

23-Sep-2014 By Zachary Brennan

CRO Covance and Fresenius subsidiary Frenova Renal Research are collaborating to find more effective treatments for patients living with chronic kidney disease (CKD) and end stage renal disease (ESRD).

Concerns raised over FDA’s informed consent draft guidance

22-Sep-2014 By Zachary Brennan

The US FDA was flooded with comments on its draft guidance seeking to amend the informed consent process – with some saying the guidance will further confuse patients while others took issue with what the revisions didn’t include.

TransCelerate hones in on two aspects of new risk-based monitoring methodology

22-Sep-2014 By Zachary Brennan

TransCelerate’s new RBM (risk-based monitoring) methodology focuses on the use of technology and centralized monitoring to shift away from Source Data Verification (SDV) to risk-driven monitoring, according to two papers in the Drug Information Association's Therapeutic...

Evotec looks to recover payments from Andromeda over faked Phase III data

18-Sep-2014 By Dan Stanton

Evotec has taken legal action to recover €3.4m ($4.4m) in milestone payments from Andromeda Biotech which was found to have faked data in a Phase III trial.

Parexel adds two clinical tech companies to partner program

16-Sep-2014 By Zachary Brennan

CRO (contract research organization) Parexel International has allowed clinical technology companies CRF Health and Clinical Ink to join its Perceptive Partner Program. 

Quintiles continues seeking more small biopharma with new solution

15-Sep-2014 By Zachary Brennan

Recognizing the critical role of emerging biopharma companies and their recent influx of cash, Quintiles has launched a new ‘emerging biopharma solution’ that aims to capitalize on the unique development needs of the companies.  

Medidata, Icon partner on electronic patient-reported outcomes

11-Sep-2014 By Zachary Brennan

Cloud-based solution provider Medidata and CRO Icon have launched a joint initiative to bring new efficiency to the administration of electronic patient-reported outcomes (ePROs) in clinical trials. 

WCG looks to galvanize northeast clients with New England IRB acquisition

10-Sep-2014 By Zachary Brennan

WIRB-Copernicus Group (WCG), a provider of regulatory and ethical review services for clinical research, announced today it has acquired New England Independent Review Board (IRB). 

PRA Health Sciences evaluates IPO option again with SEC filing

10-Sep-2014 By Zachary Brennan

A little more than a year after it was acquired by private equity company KKR (Kohlberg Kravis Roberts & Co.) for $1.4bn, newly rebranded PRA Health Sciences is looking to go public with an IPO.

Mid-sized biopharma key to strategic partnerships, Quintiles CEO says

09-Sep-2014 By Zachary Brennan

Strategic partnerships - always a hot-topic for CROs – are becoming almost exclusively a big issue for mid-sized biopharma, though small biopharma and large pharma companies are interested as well, Quintiles CEO Tom Pike said Monday at the Morgan Stanley...

More CROs expected to go public, Parexel CFO says

04-Sep-2014 By Zachary Brennan

Parexel’s future course may depend on  the outlook of competing CROs (contract research organizations), a couple of which could potentially go public in the near future, Ingo Bank, SVP and CFO of Parexel, said Wednesday at the Baird 2014 Healthcare Conference.

Update

Former Cetero researcher rebukes US FDA over warning letter

03-Sep-2014 By Zachary Brennan

A former researcher of the now dissolved CRO Cetero Research told us the warning letter he received from US FDA was “contrived” because of the way the inspection was conducted.

EDC more critical in biopharma trials than small mol studies says expert

29-Aug-2014 By Gareth Macdonald

Smaller pipelines make keeping to timelines particularly important in biopharmaceutical trials according to Exco InTouch, which says this pressure is driving EDC tech adoption.

Standardising trial measurements could stop ‘wasteful’ research

28-Aug-2014 By Fiona Barry

Regulators are showing interest in a database of clinical trial endpoints to cut redundant research, although contract research organisation Parexel has expressed reservations.

ICH plans new guidance on multi-regional clinical trials

25-Aug-2014 By Zachary Brennan

As the US FDA, EMA and Japan’s PMDA have released guidelines and related position papers on multi-regional clinical trials, the ICH is now proposing to do the same but with a more multi-national approach.

Former Cetero researcher hit with US FDA warning letter

20-Aug-2014 By Zachary Brennan

A researcher with the now dissolved CRO Cetero Research received a warning letter released Tuesday from the US FDA after inspectors found that he, among other things, failed to ensure that the investigation was conducted according to plan.

ICH seeks bids to replace Northrop Grumman as MedDRA contractor

13-Aug-2014 By Gareth Macdonald

The ICH is looking for a new manager for its MedDRA international regulatory terminology standards system to replace current contractor, aerospace and defence technology giant Northrop Grumman.

Venn acquires part of French CRO for about €500k

12-Aug-2014 By Zachary Brennan

In its third acquisition in the past 10 months, European CRO (contract research organization) Venn Life Sciences has acquired Cardinal Systems, a France-based CRO specialising in data management and randomisation systems.

Biotech cash to be a boon for CROs, Parexel says

11-Aug-2014 By Zachary Brennan

As small and medium sized biopharma companies continue to raise cash through IPOs and elsewhere, CROs will see an uptick in outsourced work, Parexel founder, chairman and CEO Joseph von Rickenbach predicted in the company’s earnings call last week.

Quintiles partnership to offer companion diagnostic services in China

07-Aug-2014 By Zachary Brennan

Roche subsidiary Ventana Medical Systems has agreed to partner with Quintiles to offer companion diagnostic testing services in China for pharma and biotech clients conducting early phase clinical trials. 

Premier acquires clinical surveillance software provider for $117m

06-Aug-2014 By Zachary Brennan

Healthcare company Premier has purchased Hospira subsidiary TheraDoc, a provider of electronic clinical surveillance, for $117m (€87.5m).

Pfizer, Roche join consortium of adaptive trial sponsors

05-Aug-2014 By Zachary Brennan

Pfizer and Roche have joined a consortium of clinical trial sponsors that are looking to design and implement adaptive trial designs. The consortium was partly founded by CRO Icon’s new subsidiary Aptiv Solutions. 

BioClinica, Isis relationship maturing with age

31-Jul-2014 By Zachary Brennan

BioClinica, a provider of clinical trial management tools, is helping Isis Pharmaceuticals and its antisense drug development program bring on more and larger clinical trials, including 16 trials for 2014.

Covance finds early phase work rebound in Q2 as central labs growth continues

31-Jul-2014 By Zachary Brennan

The season of quarterly reports is in full swing, with CRO Covance seeing its income and revenue rise in Q2 compared with the same quarter last year due to stronger-than expected early phase development and central labs work.

Medidata sees revenue growth in Q2 as new clients spike

30-Jul-2014 By Zachary Brennan

Cloud-based solutions provider Medidata saw its revenue increase 22% over Q2 last year to $83.2m as the company’s customer base saw steep growth.

WIRB-Copernicus Group acquires biosafety consulting firm Alliance Biosciences

24-Jul-2014 By Zachary Brennan

WIRB-Copernicus Group (WCG), a provider of regulatory and ethical review services for clinical research, has acquired biosafety consultancy Alliance Biosciences. Financial terms of the deal were not disclosed.

Philanthropist gives $650m to Broad Institute for psychiatric research

24-Jul-2014 By Zachary Brennan

Philanthropist Ted Stanley has gifted $650m to the Broad Institute as part of a wider attempt to galvanize research on psychiatric disorders and bring new treatments to market. 

Accovion continues expansions across Europe

23-Jul-2014 By Zachary Brennan

Germany-based full-service CRO (contract research organization) Accovion has expanded European presence with new offices in Italy, France and Eastern Europe.