ACT

JAN.10/2017


news roundup

What QuintilesIMS Predicts for Drug Development

Novel mechanisms of action that tackle underlying disease processes is but one of the forecasts for the next five years.


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Are Local IRBs Really Necessary?
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EU Not Happy with Sponsors' Pediatric Drug Commitments

EU parliament says the rules for patent extension through pediatric research are not being adhered to and industry is not completing its pediatric research plans.


Schulman IRB Joins IRB Choice and Smart IRB

Schulman IRB joins two networks that support streamlining the IRB review process in multisite research, and advocating single IRB review of multisite studies.


Rare Diseases Research Receives Boost in EU

Initially, the network, known as ERN-LUNG, will aim to create an infrastructure to promote research in the different sub-themes of rare respiratory diseases that it is focusing on.

In this edition

Updated CDISC Glossary
Need Guidance for Endpoint Adjudication?
EU Not Happy with Sponsors' Pediatric Drug Commitments
Oncology—Specimatch Offers Trial Matching Service for Cancer Patients

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Pediatric Oncology Trials: Changes on the Horizon
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ONCOLOGY

Moffitt Cancer Center Chooses Cryoport

Moffitt Cancer Center has chosen cryogenic logistics company, Cryoport to provide support for its immunology program, cancer research, therapy programs and lab moves.


Specimatch Offers Trial Matching Service for Cancer Patients

Specimatch announced its web-based software service for cancer patients and oncologists, that provides clinical trials matched to a patient's genetic and clinical profiles.


Best Countries for Oncology Research

The KMR Group's oncology-focused report highlights the strength of Eastern Europe, which now ranks second regionally right below Asia (excluding Japan).


Transformative Directions in Oncology Trials

Clinical trial designs haved evolved to strike a balance between having too permissive or too restrictive eligibility criteria that can impact study success and timely completion.


Articles

Need Guidance for Endpoint Adjudication?

In order to shed light on endpoint adjudication, the LinkedIn Endpoint Adjudication Community generated an Events Charter Template to assist those in need of guidance.


Updated CDISC Glossary

The purpose of the CDISC Glossary is also to serve the community of clinical researchers by selecting and defining terms pertaining to clinical research, particularly eClinical investigations, sponsored by the pharmaceutical industry or a federal agency.


Blog Posts

Standardized Metrics Don't Capture All Trial Risks

While advancement in the use of standardized metrics is a plus, risk-mitigative business operational processes, and uncovering unknown risks are also important to trial execution.


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Lisa Henderson
Editor in Chief
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Mike Tessalone
Publisher
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