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Headlines > Commercial Services

Survey: nearly two thirds of respondents now use CROs

28-Jul-2016 - As part of a recent survey, 62% of respondents said they are more likely to engage a clinical research organization (CRO) partner for clinical research than they were five years ago.

CROs, Sponsors recognize need for improvement, opportunities

26-Jul-2016 - According a recent survey, while there is a disconnect between Sponsors and Providers in some areas, the industry as a whole agrees that there is room for improvement.

Bioclinica acquires clinical research company

25-Jul-2016 - The acquisition of Compass Research expands Bioclinica’s access to several specialized populations with neurodegenerative disorders and other diseases.

Questions surrounding Indian CRO result in medicine suspension recommendation

22-Jul-2016 - The EMA is recommending the suspension of several medicines after inspections revealed flawed studies at the India-based contract research organization (CRO), Semler Research Centre.

PPD awarded for innovative eTMF development

21-Jul-2016 - Pharmaceutical Product Development (PPD) has won the 2016 OpenText Elite Award for the Most Innovative Project in the Health Sciences Sector.

Lonza: Biologic APIs boosted H1 revs and CAR-T deal will help sustain growth in H2

20-Jul-2016 - Lonza has increased its 2016 earnings guidance after strong H1 growth of its biologic APIs business.

CSafe opens new service center in Puerto Rico

18-Jul-2016 - The cold chain solution company, CSafe, has opened a new San Juan-based service center in conjunction with the launch of its new company, CSafe Puerto Rico LLC.

Enrolling patients and keeping them: electronic patient recruitment companies collaborate

18-Jul-2016 - eClinicalHealth and Clinerion have announced a collaboration under which the companies will offer their complementary technologies jointly to hospitals and sponsor companies/CROs.

DIA 2016

FDA, EMA leaders address barriers, 'big projects,' and Brexit

13-Jul-2016 - Senior leadership from key regulatory bodies gathered at the DIA 2016 Annual Meeting to discuss challenges they face as global regulators, both domestically and as part of international cooperative initiatives.

NIH: million-person precision medicine study 'a constant learning process'

12-Jul-2016 - The Precision Medicine Initiative (PMI) Cohort Program  is expected to launch later this year with the goal of enrolling more than one million US participants by 2020.

KaloBios CEO on its post-Shkreli 'restart'

11-Jul-2016 - After announcing a new pricing model that promises transparency, affordably, and reasonable return, KaloBios has emerged from bankruptcy – but transparency moving forward will be a shared burden.

Sequence and Adents team to help pharmas follow track & trace rules

07-Jul-2016 - Compliance consultant Sequence Inc. has partnered with software firm Adents to develop a track & trace solution for pharmaceutical products.

CAD software brings aerospace technology to the pharma industries

05-Jul-2016 - The pharma industry could learn valuable lessons from the aerospace and automotive industries when it comes to designing new products, according to Swiss researchers.

DIA 2016

Fatality in clinical trials: DIA panel discusses FIH trials

29-Jun-2016 - After the Bial trial tragedy earlier this year, panelists gathered at DIA to discuss what went wrong and how to move forward as an industry. 

Sartorius $90m IntelliCyt acquisition adds cell analysis capabilities

29-Jun-2016 - Sartorius has expanded its bio-analytics capabilities through the $90m (€81m) acquisition of IntelliCyt.

DIA 2016

Survey: paperless TMF advantages and progress

27-Jun-2016 - According to a recent survey, there are significant advantages to adopting eTMF – although some challenges still remain in the shift towards paperless clinical trials.

DIA 2016

'Now is the time to include Japan' says Parexel

24-Jun-2016 - Japan “welcomes innovation” as it makes significant investments in infrastructure and regulatory changes.

Marken expands as clients seek to ‘find suitable patients’ in remote areas

23-Jun-2016 - Marken has announced it is expanding its offerings to remote areas of the world, as clinical trials become increasingly more complex.

DCAT Sharp Sourcing to address key outsourcing issues

22-Jun-2016 - DCAT Sharp Sourcing 2016 is a conference and networking event presented by the Drug, Chemical & Associated Technologies Association (DCAT).

NIH issues multi-site research policy to streamline IRB review

21-Jun-2016 - The National Institutes of Health (NIH) has issued a policy on the use of a single Institutional Review Board (IRB) for multi-site research with the goal of streamlining the IRB...

Comparing ClinicalTrials.gov and FDA review for accuracy and completeness

20-Jun-2016 - Clinical trial sponsors are required by law to report results to ClinicalTrials.gov; however it’s not clear if these posts are complete and accurate.

Dispatches from BIO 2016

How (and why) CROs are collecting and using patient-centric data

16-Jun-2016 - The advent of low-cost, real-time technologies has made capturing real-world patient experiences easier than ever, allowing CROs to address concerns over end-use needs.

Update

Almac facility successfully passes FDA inspection

14-Jun-2016 - The global contract development and manufacturing organization (CDMO) announced that its Durham, North Carolina-based facility completed a successful US Food and Drug Administration (FDA) inspection.

Analyst says 4th CRO may shake up Pfizer's deals with Icon, Parexel, and PPD

14-Jun-2016 - Icon and Parexel recently announced renewals with pharma giant Pfizer, but according to analysts, PPD and an unknown fourth player may disrupt business as usual.

update

Prosecutors examining fatal BIA-10-2474 trial start manslaughter investigation

14-Jun-2016 - French authorities have started a manslaughter investigation in connection with a Ph I trial  conducted by Rennes-based CRO Biotrial in which one volunteer died and five others were hospitalised....

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