In this ISSUE

Real-World Evidence Studies

CTMS: What You Should Know

ICH GCP Goes Risk Based

Clinical Operations

Overcoming Delays in Europe's Advanced Therapies

As concerns grow about the slow progress of advanced therapies, drug developers are pushing for action from European authorities.
... /Read more/

ERT Video Series
Check out the ERT video series, filmed on the show floor at DIA 2017, for interviews on Innovating Clinical Trial Management, eCOA in Clinical Research: Trends and Advances, and Optimizing Clinical Trial Imaging through Advanced Technology.

Click here to watch all 10 short videos

Tomorrow's Clinical Trial, Powered by Modern EDC
See how to cut study build time in half, eliminate migrations, and remove the need for source data verification (SDV).

See a preview and watch the full webinar here.

Calendar

/ Partnerships in Clinical Trials Europe 11/28-11/29 /

/ BioPharma Forum on Cannabis-Based Therapies 11/30-12/1 /

/ Clinical Trial Legal and Contracting Forum 12/5-12/6 /

/ eCOA/ePRO 2017 12/13-12/14 /

CRO Outsourcing

The Emergence of the Few: M&A in the CRO Industry

As the size, complexity, duration, cost, and globalization of clinical trials has grown, pharmaceutical and biotech companies have moved to outsource clinical activities to CROs to achieve a wide range of objectives.
... /Read more/

Exom Group is "The Human Digital CRO" , that provides value-added services through digital applications for clinical development of drugs & medical devices. We combine the strong medical, regulatory and operational expertise of our staff , with the most disruptive digital cloud and mobile solutions to reduce costs and increase quality and performance of Clinical Trials. We can manage studies in all Europe and USA.

Learn more

Biosimilars

Do Biosimilars Require Clinical Trials?

Jill Wechsler talks about biosimilars and the requirement of clinical trials in her recent blog.
... /Read more/

Rare Diseases and the Eye - Envisioning Strategies for Success
Live Webcast: Friday, October 27 at 11:00am EDT

Exclusive Interviews from the 2017 DIA Global Annual Meeting
Check out these exclusive interviews from the 2017 DIA Global Annual Meeting in Chicago, IL, conducted by the editors of Pharmaceutical Executive and Applied Clinical Trials. Whether or not you attended the event, here is your chance to gather insights from featured industry professionals.

Watch Videos

Ask the editor

Lisa Henderson
Editor in Chief
Lisa.Henderson@ubm.com

Navigating the Regulatory Complexities of Orphan Drugs: Know the unwritten rules of designations and what's next
Live Webinar: Thursday, November 2 at 11:00am EDT

Patient Centricity

Four Pillars to Achieve Patient Centricity

ZS Associates specify the four pillars of patient centricity that can help the demands and complexities of clinical trials.
... /Read more/

RBM Technology Impact on Clinical Roles: Centralized Monitoring is streamlining activities and changing roles across clinical development
On Demand

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Regulatory Authorities, EMA

EMA Relocation Worries Intensify in the Final Stages of the Decision

Tensions mount across the European pharmaceutical scene over the fate of the EMA with just weeks before the final decision is going to be made on where it will be moved to.
... /Read more/

Proactive Planning, a Transformational Revolution to Improving Clinical Trial Quality?
On Demand

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Future-proofing your Pharmacovigilance Delivery Model: Achieving scalability and cost effectiveness with AI/smart machines
Live Webinar: Wednesday, October 25 at 11:00am EDT

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Mike Tessalone
Publisher
Michael.Tessalone@ubm.com

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