Validation services

From CPHI India 2014

Indian manufacturing problems spur growth... for testing companies

03-Dec-2014 By Fiona BARRY

SGS has doubled testing capacity at its Mumbai facility, explaining that Indian API makers’ failure to invest in quality has been good for business.

Demand for early formulation work to tackle drug target ‘Wild West’

18-Nov-2014 By Fiona Barry

Sponsors are turning to outsourcing earlier for help with bioavailability formulation, say contract research organisations (CROs)

'Killer experiments' and reimbursement are the keys to VC backing says Index

17-Nov-2014 By Gareth Macdonald

Investors only back drug innovators because they have to according to Index Venture Management's Kevin Johnson, who says less risky 'first to be second' firms are actually much more attractive.

Thermo Scientific issues software update after confirming bug in its bioequivalence data platform

04-Nov-2014 By Dan Stanton

Thermo Fisher Scientific has issued a letter to users of its Kinetica technology software confirming discrepancies in its bioequivalence data.

Sterigenics buys amid speculation PE backer is looking to offload

04-Nov-2014 By Gareth Macdonald

Sterigenics International has bought Italian gamma-ray sterilisation firm Gammarad in a deal that comes amid rumors that private equity owner GTCR is looking to offload the Illinois-based contractor.

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.

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.

Phøenix from the flåmes? Swedish firm makes the most of old AZ site

23-Oct-2014 By Fiona Barry

A process development firm founded by ex-AstraZeneca employees says closure of the drugmaker’s Swedish R&D site gave it technical knowhow and former colleagues as customers.

Consultant: Commercial bioequivalence software in need of validation in wake of Thermo Scientific's review

22-Oct-2014 By Dan Stanton

A bioanalytical consultant has stressed the importance of drug developers testing commercial off-the-shelf (COTS) software following the discovery of potential issues with Thermo Scientific’s bioequivalence Kinetica platform.

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.

Marken expansion into Latin America continues with Chile, Peru depots

09-Oct-2014 By Zachary Brennan

Fresh off the near completion of its depot in Sau Paulo, Brazil, Marken has now also completed the construction of another depot in Santiago, Chile, in order to more easily handle the influx of clinical trial specimens coming from South America.

LabCorp to acquire NMR-focused, personalized diagnostic company LipoScience for $85m

29-Sep-2014 By Zachary Brennan

CRO LabCorp has entered a definitive agreement to acquire LipoScience for $5.25 per share, or about $85.3m (€67.2m).

Research accreditation program signs off on three new organizations in US, Mexico

23-Sep-2014 By Zachary Brennan

The Association for the Accreditation of Human Research Protection Programs today announced that it has accredited three more organizations, including two independent institutional review boards (IRB) in Massachusetts and a third organization in Mexico.

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. 

Marken opens clinical trials depot in trial haven of Brazil

11-Aug-2014 By Zachary Brennan

Supply chain specialist Marken announced last week the opening of their newest clinical trials depot in Sao Paulo, Brazil to help sponsors and CROs looking to conduct trials there and elsewhere.