Sandoz Wins Biosimilar Filing Race
After months of speculation about prospects for biosimilar development in the US, Novartis announced July 24 that FDA has accepted Sandoz' biologics license application ...
Study Events: Keeping your Trial Master File Up-To-Date as Your Trial Evolves
It's a given that events will happen during the course of the trial that will require not just new documents, but new sets of documents.
European Society for Medical Oncology: Is Europe Putting Cancer Research at Risk?
ESMO concerned that the proposed EU General Data Protection Regulation could make cancer research impossible and add a significant burden to cancer patients
ESMO Voices Deep Concern About Future of Cancer Research
ESMO is concerned that the proposed European Union General Data Protection Regulation could make cancer research impossible and add a significant burden to both doctors and cancer patients.
WIRB-Copernicus Group Announces Acquisition of Alliance Biosciences; Executives Join WCG Biosafety Division
Expanding bio-risk management support for federal, state and institutional laboratories
Astra Nova and ACRES Partner on Quality and Access of Training for Research Professionals
Astra Nova Training and ACRES announced a strategic alliance collaboration
FDA Sentinel: Catching Biopharmaceutical Sponsors by Surprise
This article will discuss FDA's post-marketing surveillance programs, and how biopharmaceutical sponsors can work with the FDA to identify unreported Adverse Events.
TransCelerate Selects Cognizant for Shared Investigator Platform
Cognizant announced that it has been selected by TransCelerate BioPharma Inc. to develop a subscription-based platform
TransCelerate Selects Cognizant to Develop a Clinical Trials Collaboration Platform
The Shared Investigator Platform, Built as an Industry Utility, Will Help Accelerate the Development of New Medicines
Astra Nova Training and ACRES announced a Strategic Alliance collaboration.
Chesapeake IRB Completes Acquisition of IRB Services
Adds largest independent and only AAHRPP-accredited Canadian IRB/REB to the Chesapeake IRB organization
Chesapeake IRB Announces Acquisition of Goodwyn IRB
Combined Assets Expand Expertise and Reach
CTI Clinical Trial and Consulting Services Opens Sao Paulo, Brazil Office
CTI Clinical Trial and Consulting Services announces that it has opened an office in S?o Paulo, Brazil
Chesapeake IRB Acquires Two IRBs
Chesapeake IRB has acquired Goodwyn IRB and IRB Services
CTI Opens Office in Brazil
CTI Clinical Trial and Consulting Services has opened an office in Sao Paulo, Brazil.
MCC Metric of the Month Blog: A Second Risk-Based Monitoring Metric
MCC has just published an executive summary of its Risk Based Monitoring Usage Survey.
Techorizon's New Approach to eClinical Solutions Launched at DIA
One event which you may have missed at DIA was the launch of a new suite of eClinical solutions by Techorizon.
EMA Issues Robust Response to Conflict of Interest Claims
EMA has insisted that the concerns raised about its scientific advice given to pharmaceutical companies stem from a flawed understanding of the activities of the agency and its partners in this area.
NIH Translational Research Partnership Yields Promising Therapy
A potential treatment for sickle cell disease has come through early stage development due to support from a collaborative partnership established by NCATS at the NIH.
WIRB-Copernicus Group Announces Acquisition of Alliance Biosciences
WIRB-Copernicus Group announced that it has acquired Alliance Biosciences.
PatientsLikeMe Offers Three Services for Pharma and Researchers
Dr. Paul Wicks, head of innovation at PatientsLikeMe, detailed for Applied Clinical Trials, the three services the company announced at DIA.
Biotie Therapies Selects Bracket's CDR System for Phase II Parkinson's Trial
Bracket announced that Biotie Therapies has selected its CDR System for use as the primary endpoint for their Phase II trial.
Is it Time to Lock up those who Commit Research Fraud?
Two experts have engaged in a lively debate about whether research fraud should be classed as a criminal act.
Chiltern Acquires Ockham
Chiltern and Ockham announce that Chiltern has acquired 100% of Ockham and that the companies will merge their operations.
Chiltern Acquires Ockham and the Companies Merge Operations
Chiltern and Ockham today announce that Chiltern has acquired 100% of Ockham and that the companies will merge their operations.
Business and People July 2014
Industry news focusing on the people and organizations who work in the clinical trials profession.
Should Research Fraud be a Crime?
On thebmj.com today, two doctors debate whether research fraud should be classed as a criminal act.
FDA Releases Draft Guidance for IRBs, Clinical Investigators, and Sponsors on Informed Consent Information Sheet
This guidance document is being distributed for comment purposes only.
Latest Clinical Conductor Release Debuts First-Ever CTMS Configurations
The Clinical Conductor CTMS team is proud to announce yet another major advancement in CTMS technology.
Theorem Clinical Research and Excel Life Sciences Form Strategic Relationship
Theorem Clinical Research and Excel Life Sciences (ELS) have formed a strategic relationship