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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....

Pfizer sticks with Parexel and Icon

13-Jun-2016 - After much speculation, Pfizer has confirmed it will renew its service agreements with its largest contract research organization customers – as analysts suspected . 

Dispatches from BIO 2016

Who defines value? Quintiles talks changing reimbursement landscape

09-Jun-2016 - With the emergence of the empowered patient, the reimbursement landscape is shifting and stakeholders must navigate who really holds the power – and how this changes the definition of value.

ASCO 2016

Social media speeds study recruitment for cancer researchers

07-Jun-2016 - Researchers used pre-existing platforms to identify and recruit patients for a cancer research study – connecting advocacy groups, social media, and a dedicated website to register patients.

GSK's real-world Relvar trial called for 'game changing' tech says North West e-Health

02-Jun-2016 - A real-world trial of GSK's Relvar has prompted the development of a ‘game-changing’ database linking and tracking tech according to North West e-Health.

Quintiles: clinical trial complexity demands innovative approaches

01-Jun-2016 - Quintiles has announced a new model designed to accelerate site start-up and patient recruitment in oncology clinical trials to 21 days.

Industry talks patient centricity in clinical trials

23-May-2016 - Last week, Medidata held a Twitter chat on patient centricity in clinical trials in which several industry professionals came together to talk about the challenges and opportunities of implementing patient focused practices. ...

Patient collaboration barriers and the 'willingness to iterate forever'

23-May-2016 - Patients must be more involved in trials according to ex Google Chief Health Strategist, who told sponsors and CROS that increasing engagement is key to moving forward.

Veeva launches product-specific cloud-based data management system

19-May-2016 - Veeva Systems has expanded its cloud-based software offering with a system that allows drug firms to manage product specific data.

Exclusive interview

Clinical Trials Day: focusing on awareness, the ‘war on talent,’ and an industry-wide commitment

19-May-2016 - Clinical Trials Day celebrates the first randomized clinical trial conducted in May 1747 and the clinical research professionals that work in the industry more than 265 years later.

Clinical trial trends: wearables, social media top list

18-May-2016 - A recent survey identifies wearable technology and social media recruitment as the leading trends in clinical trials – and EHRs as a “major hurdle.”

Will Pfizer renew with Icon, Parexel? Analyst says yes

17-May-2016 - This month marks the renewal period for Pfizer’s contract research organizations’ Icon and Parexel, and while revenues have been declining, analysts believe the pharma giant will renew with both companies....

CRO performance tracking tool sets 'realistic expectations'

16-May-2016 - While the competitive market keeps CRO pricing in relative check, there hasn’t been an effective way to track CRO performance.

Bitcoin tech to improve clinical trial research transparency

16-May-2016 - In an effort to improve transparency in clinical trial research, two doctors created a system that coverts trial documents into a Bitcoin – an online equivalent of cash.

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