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FDA Releases Draft Guidance for IRBs, Clinical Investigators, and Sponsors on Informed Consent Information Sheet
This guidance document is being distributed for comment purposes only.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
Theorem Clinical Research and Excel Life Sciences have formed a strategic relationship.
Bio-Optronics Releases New Version of CTMS Technology
Bio-Optronics' Clinical Conductor CTMS team announced new features in the latest release of Clinical Conductor
MedNet Solutions Receives First Major Outside Financing
Funds to Accelerate iMedNet EDC Sales, Marketing and R&D Initiatives
Innovations in Assessing Cardiac Proarrhythmia Risk: New Strategy may Improve Cardiac Safety while Preserving the Drug Development Pipeline
Why the requirement for the collection of cardiac safety data?
French Plans to Cut Spending Through Off-label Medicines Jeopardizes Patient Safety and Challenges EU Regulatory Standards
The European Confederation of Pharmaceutical Entrepreneurs is very concerned about legislative developments on the use of off-label medicines in France.
EFPIA Unveils Action Plan for Lithuania
The Lithuanian Ministry of Health and EFPIA have announced a new Joint Working Agreement.
Orphan Drug Approvals Have Increased, But High Costs Pose Challenges for Patients, According to the Tufts Center for the Study of Drug Development
Although the pace of approvals for new orphan drugs have increased in the United States and Europe in recent years, patients are facing growing challenges accessing those drugs.
Top Reasons Patients Join Clinical Trials
Recruiting patients remains one of the most difficult challenges clinical trial sponsors face.
EMA Delays Decision on Clinical Trial Data until October
EMA has postponed formal adoption of the policy on publication of clinical trial data until its October 2, 2014 meeting
Tufts CSDD Report Finds Orphan Drug Approvals Have Increased, But Challenges Exist
ACRES and inVentiv Health Partner to Promote Operational Excellence and Shared, Global Clinical Research Platform
inVentiv Clinical Trial Recruitment Solutions and the Alliance for Clinical Research Excellence and Safety are partnering toward the development of a global system
Experts Tell Congress How to Streamline Clinical Trials
Key to accelerating the discovery and development of new medical therapies is to improve the clinical research process.
Management Board Delays Formal Adoption of EMA Publication of Clinical Trial Data Policy to October 2014
Further discussion required on wording and practical arrangements
EFPIA: French Legislation Undermines EU Regulatory Framework by Endorsing Off-label Use of Medicines for Economic Reasons
EFPIA criticized the intent of the French government to broadly enlarge the use of off-label drugs for economic reasons, even if there is an approved drug available.
French Legislation Comes in for Strong Criticism
The French government's intention to broadly enlarge the use of off-label drugs for economic reasons is wrong, according to a statement issued by EFPIA
Pharmaceutical Body EFPIA and Lithuanian Ministry of Health Galvanise Future Innovation and Improvements to Public Health with Landmark Joint Working Agreement
he Lithuanian Ministry of Health and EFPIA, the European Federation of Pharmaceutical Industries and Associations announced a significant new Joint Working Agreement that paves the way for protecting future health and growth in Lithuanian.
inVentiv's Otis Johnson Joins Site Optics and Quality Informatics Steering Committee for Development of Industry Wide Site-Based Performance Metrics and Informatics Standards
ACRP, ENACCT Partner on Cancer Trials Recruitment Professional Education
ACRP and ENACCT announced the integration of key ENACCT products and services into the current ACRP professional development portfolio.
