Shire plc announced today that it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for SPD465, an investigational amphetamine compound for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in the adult population.
Five new clinical trial sponsors brought by COResearch will utilize the DATATRAK eClinical™ platform for international cardiac safety studies for drugs and devices
Tools for Clinical Trials Professionals
ACT BPA June 2006
Dr. Sanjay Gupta, senior medical correspondent for CNN, practicing neurosurgeon, and assistant professor of neurosurgery, delivered the Keynote Address at the 42nd DIA Annual Meeting on Monday morning.
DIA President, Theresa Kane Musser, Executive Director, Development Operations, Rigel Pharmaceuticals, presented the awards
CTI Clinical Trial and Consulting Services (CTI) and Harrison Clinical Research (HCR) are proud to announce their new collaboration focusing on the expansion of the clinical trial capabilities of both organizations.
In the afternoon, ACT columnist Ken Getz, MS, MBA, chaired the session: "Prevention of Fraud and Noncompliance in Clinical Research." Ken was joined by speakers David Cocchetto, PhD, RPh, of GlaxoSmithKline, and Dara Katcher, JD, of the Washington, DC law firm, Hyman, Phelps & McNamara.
On Monday, Peter DiBiaso, MHA, director of clinical trial recruitment services for Pfizer, chaired the session: "Championing the Patient Perspective in Clinical Study Recruitment and Retention: The Role of Sponsor, CRO, and Vendor in Successful Strategy Development."
Representatives of FDA, EMEA and industry discussed their pilot program to provide parallel scientific advice to sponsors developing new drugs. The process aims to resolve critical clinical and safety issues early in the research process to avoid duplicative testing and regulatory delay.
In an afternoon session examining innovations in the development of anticancer medicines, speakers from the research, therapeutic, regulatory and industry perspectives discussed "Changing the Paradigm: Innovative Oncology Drug Clinical Development Programs in the Age of the Critical Path and Personalized Medicine."
In a Monday morning session entitled "Patient-Reported Outcome Instruments: Overview and Comments on the FDA Guidance," CDER officials stressed the importance of including PROs early in the clinical trial planning process, rather than at data analysis stages. Edwin P. Rock, MD, PhD, medical officer, division of drug oncology products, described the endpoint model/conceptual framework that organizes the amount/type of data for various uses.
Multiple partnerships formed over past year using SAS Drug Development, SAS Enterprise Intelligence Platform
Solution addresses biomarkers, incorporates molecular information
Acquisition will expand clinical pharmacology bed capacity and broaden Covance's access to special patient populations for Phase Ib/IIa studies.
Combined Advanced Technologies Enable Both Traditional and Adaptive Clinical Trials
BBK Adds Global Alliances and Restructures Offerings to Advance Patient Recruitment.
InForm Adapter, Available Immediately, Strengthens Integration with Existing Customer Data and Systems.
ClinPhone will be exhibiting its complete range of clinical trial technology services at the 42nd DIA Annual Meeting.
CoSign electronic signature reduces the time and cost of clinical trials, helping sponsors and CROs comply with the FDA's 21 CFR Part 11 and GxP regulations.
Green Mountain Logic will unveil LabPAS/CT Version 2.5 at the DIA Annual Meeting.
DataLabs is the first vendor to implement electronic signatures out-of-the-box guaranteeing signer authenticity and data integrity.
Datafarm announces the release of a simple and cost effective Web-based eCTD viewer for companies of all sizes.
New integration platform leverages a library of predefined connectors and allows clients to write their own custom connectors, easing the pain of creating and managing system integrations.
TrialMaster V.4.0. is a flexible, painless, and affordable eClinical Solution.
Welcome, Awards Presentation, Keynote Address and Hot Topics
Ultra-Scan's TouchLink Solution Allows CROs to Accurately Identify Patients and Ensure Study Integrity.
OneClinical Provides a Full Spectrum of Software Products and Services for the Regulated Life Sciences Industry.
Plenary sessions
Electronic solutions such as IVR systems, PDAs, and digital pens exhibit advantages over paper and pencil in PRO data collection.
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