An adaptive design is a design that allows for modifications to the processes and statistical procedures of a clinical trial, usually at set intervals established in the trial protocol. Adaptive designs are useful for increasing efficiency and lowering costs associated with clinical research. Studies incorporating adaptive design techniques can be useful in redirecting subject allocation to concentrate on the most promising treatments or in stopping a trial early for futility. The temporal and monetary savings resulting from adaptive designs make them of great value in drug and medical device development.
The purpose of a comprehensive assessment system is to support structured, systematic, objective, and rational decision making. This holds true even when assessing something as difficult to pin down as risk.
Preparations for a large Phase 3 clinical trial will always present challenges. In the area of gene therapies, those challenges can be magnified. Gene therapy trials can add more time and cost to a trial, and will also require specific expertise not needed in small molecule and biologics trials.
Robert Homolka, Director of Clinical Pharmacology Operations at Shire, feels the support the Clinical Pharmacology group provides to the clinical development programs is one of the more important aspects of his job. Studying and ensuring the safety of a drug is of primary importance to the sponsor, and clinical pharmacology is front-and-center in leading that effort.
Avoid study delays, increased patient costs, and compromised study data with Bioclinica's program that swiftly and efficiently locates patients who are lost to follow-up, following all privacy and compliance guidelines.
Understand the benefits and challenges of conducting studies in Latin America in addition to some recent changes that could expedite regulatory timelines.
How global site networks can effectively address timeline, budget and data quality concerns, by providing access to multiple experienced sites within a single network, providing cost savings through reduction of the total number of sites used and recruitment of a large volume of patients.
Change the perception of clinical trials by making them less burdensome for patients overall.
ICON plc is a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries. The company specializes in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently, operates from 97 locations in 38 countries and has approximately 13,100 employees.
To be successful, your molecule deserves unparalleled experience in Alzheimer’s Disease clinical research. You need a research partner with an uncommon understanding of the complexities associated with evaluating patients with various phenotypes and the ability to implement specific design features to mitigate the risks and challenges specific to Alzheimer’s studies.
Worldwide Clinical Trials employs more than 1,400 professionals around the world, with offices in North and South America, Eastern and Western Europe, Russia and Asia. One of the world’s leading, full-service contract research organizations (CROs), we partner with sponsors in the pharmaceutical and biotechnology industries to deliver fully integrated clinical development and bioanalytical services, extending from first-inhuman through phase IV studies. Grounded in medicine and science, Worldwide Clinical Trials enables sponsors to move from medical discovery into clinical development and commercialization, helping bring innovative solutions to market that deliver enhanced value and improve patient lives. Our employees are among the best in their fields – clinicians, scientists, operational and regulatory specialists who offer expertise across a range of therapeutic areas, including neuroscience, cardiovascular diseases, immune mediated inflammatory disorders (IMID), and rare diseases.
Founded by physicians committed to advancing medical science, Worldwide is out to change how the world sees CROs – in the best possible way. From Early Phase and Bioanalytical Sciences through Late Phase and post approval, we provide world-class, full-service drug development services. With infrastructure and talent spanning 60 countries, we execute predictable, successful studies with operational excellence. We never compromise on science or safety. We’re never satisfied with the status quo. We’re the Cure for the Common CRO.
Worldwide Clinical Trials is the leader in CNS clinical research. Our tradition of excellence is founded on therapeutic expertise in CNS disorders, especially psychiatry.
Worldwide’s tradition of excellence is centered on CNS therapeutic expertise and in particular in neurodegenerative disorders such as Parkinson’s disease. Our unparalleled experience in this area allows us not only to understand the complexities associated with Parkinson’s study design, but also to operationally implement specific design features through the use of innovative strategies and tools that mitigate risks and challenges inherent in this type of study.
Worldwide has extensive capabilities in global analgesia research, including experience with human experimental and clinical models for proof-of-concept in nociceptive and neuropathic pain and for registration studies to support marketing authorization in a number of acute and chronic pain indications.
Worldwide Clinical Trials takes pride in bringing a depth of knowledge to your study based on experience in trials across a range of neurologic disorders. Our clinical experience enables us to work with you at any stage of drug development from Phase I through Phase IV for traditional, as well as, highly innovative clinical targets. Worldwide has participated in the design, execution, or analysis of 105 trials, over 550 sites and 2,840 patients since 2008. Of the 105 total trials, 55 studies have included at least clinical monitoring or project management. A majority of these studies have been conducted globally including unique capabilities in Russia, Ukraine and Eastern Europe.
Blinded Diagnostics has been engaged to provide point of care diagnostics services to support a global multi-center clinical trial.
PharmaMar, a Spanish biopharmaceutical company, has selected Medidata Solutions (NASDAQ: MDSO) for its industry-leading electronic data capture (EDC) and clinical data management (CDM), safety data capture and reporting, and medical coding solutions. A member of the Zeltia Group and a leader in the development of antitumor drugs of marine origin, PharmaMar said the company’s investment in the Medidata Clinical Cloud™ will efficiently streamline its clinical trial processes in its mission to deliver drugs that treat cancer and rare ("orphan") diseases.
DATATRAK International, Inc. (OTCQX: DTRK), a leader in developing cloud-based, unified eClinical™ technologies and delivering related services for the clinical trials industry, today announced its operating results for the fourth quarter and full year of 2012.
Lithera, Inc., a clinical stage pharmaceutical company focused on lifestyle and medical indications in aesthetic medicine and ophthalmology, announced today that the first patient has been treated with LIPO-202 (Salmeterol Xinafoate for Injection) in its 500-patient Phase 2b "RESET" trial.
Telormedix, a clinical stage biopharmaceutical company focusing on toll-like receptor 7 (TLR7) small molecules in the treatment of cancer and inflammatory diseases, recently announced that it has recruited the first patient in a Phase II trial of its lead product TMX-101, a TLR-7 agonist, in carcinoma in situ (CIS) in the bladder.
Concert Pharmaceuticals, Inc. announced today that it has completed enrollment of patients in a Phase 2 clinical trial evaluating CTP-499 for the treatment of diabetic kidney disease. CTP-499 is intended to slow progression of kidney damage in diabetic kidney disease and be additive to the current standard of care, which is treatment with an angiotensin converting enzyme inhibitor (ACEi) and/or an angiotensin receptor blocker (ARB). Concert expects to report top-line results from the Phase 2 study during the second-half of 2013.
DiaMedica (TSX VENTURE:DMA) has successfully completed cGMP manufacturing of DM-199 to be utilized in upcoming clinical trials.
Amgen (NASDAQ:AMGN) today announced top-line results of the Phase 3 Aranesp® (darbepoetin alfa) RED-HF® (Reduction of Events With Darbepoetin Alfa in Heart Failure) Trial.
GeoVax Labs, Inc. (OTCQB: GOVX), an Atlanta-based biopharmaceutical firm developing vaccines to prevent and treat HIV/AIDS, announced it has completed enrollment in a nine-patient Phase 1/2 clinical trial testing the safety, immunogenicity and ability of its DNA/MVA vaccine to elicit protective immune responses in HIV-infected individuals.
Blinded Diagnostics announced the expansion of their business development efforts by appointing Patricia H. Averette, a seasoned health care professional with a solid background in Hematology Lab Diagnostics, as the new Vice President of Business Development.
The IP & Science business of Thomson Reuters, the world's leading source of intelligent information for businesses and professionals, today announced the publication of a new report that provides a comprehensive view of the potential effects of personalized medicine on drug research and development.
It’s now possible for clinical trial researchers to control time, thanks to PHT Corporation’s patented Time Travel technology.PHT is the world’s leading provider of systems used to collect patient-driven eData for clinical research.
Blinded Diagnostics recently announced the expansion of their diagnostic product portfolio with the addition of an extensive line of screening tests for drugs of abuse and alcohol from Express Diagnostics Int’l, Inc. (EDI) of Blue Earth, MN.
Peregrine Pharmaceuticals (
