WHITE PAPERS & CASE STUDIES
-
SynteractHCR Full-Service CRO Brochure
SynteractHCR is a multinational clinical research organization, formed from the merger of Synteract with Harrison Clinical Research in 2013, which provides global, full-service clinical trial services. We have more than two decades of experience supporting biopharma companies in all phases of clinical development across multiple therapeutic areas. We customize programs that will deliver timely, high quality data to help you get to decision points faster, taking time and cost out of drug development.
-
Improve Accuracy And Efficiency In Data Collection For Mental-Health Evaluations And Assessments
MedAvante is a global provider of centralized, expert psychological rating services to the pharmaceutical, biotechnology, and medical device industries.
-
Phase II Alzheimer's Case Study
A double-blind, Phase II, placebo-controlled clinical trial to evaluate the safety and efficacy of a novel compound in subjects with mild to moderate Alzheimer’s disease.
-
Moving Towards An Electronic Environment In Clinical Trials
With each passing year, clinical trials are becoming increasingly global. The business of product development is moving away from the traditional model in which studies are conducted primarily in the US – in fact, recent estimates indicate that within the next three years, up to 65 per cent of studies under FDA regulation will be conducted outside the US. A review of a US government clinical trials registry and of 300 published reports in major medical journals revealed that one third (157 of 509) of Phase III trials were being conducted entirely outside the US, with over half the study sites (13,521 of 24,206) used in these trials located overseas, many in eastern Europe and Asia.
-
Brochure: Norwich Clinical Services
Norwich Clinical Services is a contract research organization that provides Bioanalytical Services, Pharmacovigilance and Clinical Research Programs to the pharmaceutical and biotech industries.
-
Optimizing Clinical Trial Enrollment: Same Day Turnaround Of Blood Chemistry For Eligibility
Potential clinical trial participants and sponsors typically wait 2-3 days for lab results to determine eligibility. For the would-be participant every day that elapses could contribute to the loss of interest and increase the risk of losing a potential study subject for many reasons. By Paul S. Savuto, MS, MBA Blinded Diagnostics
SERVICES & PRODUCTS
CRISTal is RDP Clinical Outsourcing’s proprietary software platform that facilitates the strategic identification of sites, as well as our highly experienced regional monitors.
A leading western CRO in Russia, ClinStar offers invaluable experience to enhance your study execution, resulting in higher-quality results. We offer local regulatory, customs and logistical expertise as well as clinical teams that are therapeutically trained in CNS diseases.
Newsletter Signup
NEWS
-
NeuroDerm Announces Positive Results Of A Phase I Study Of ND0612 For The Treatment Of Parkinson's Disease
NeuroDerm, Ltd. announced today the results of a Phase I safety and pharmacokinetic trial of ND0612, a novel drug formulation for the treatment of Parkinson's disease. ND0612 is a proprietary levodopa/carbidopa liquid formula administered continuously sub-cutaneously through a patch pump. It is designed to provide steady levodopa blood levels for the reduction of motor complications in Parkinson's disease. Results of this study support the continued development of ND0612 for the treatment of Parkinson's disease.
-
Concert Pharmaceuticals Announces Completion of Enrollment in Phase 2 CTP-499 Clinical Trial
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.
-
Isis Initates Phase 2/3 Study Of ISIS-TTR Rx And Earns $7.5M Milestone Payment From GlaxoSmithKline
Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced today that it has earned a $7.5 million milestone payment from GlaxoSmithKline (GSK) related to the initiation of a Phase 2/3 clinical study for ISIS-TTRRx.
-
New Study On Emerging Markets Reports Low Marks For Asia
KMR Group, a leader in analyzing R&D performance data for the biopharmaceutical industry, completed an analysis of recent clinical work in Emerging Markets.
-
Theravance Announces Initiation Of Phase 2b Study With Its LAMA Candidate, TD-4208, For The Treatment Of COPD
Theravance, Inc. (NASDAQ: THRX) announced the initiation of a dose ranging Phase 2b study with TD-4208 as a nebulized aqueous solution in patients with moderate to severe COPD.
-
Peregrine Pharmaceuticals Announces Significant Progress In Advancing Its Cotara Program Into A Pivotal Phase III Trial
Peregrine Pharmaceuticals (
NASDAQ : PPHM), a biopharmaceutical company developing first-in-class monoclonal antibodies focused on the treatment and diagnosis of cancer, today announced that it has made significant progress in advancing its Cotara program into late-stage development through its agreement with the U.S. -
Upsher-Smith Presents Favorable Phase I Data For USL261, A Novel Formulation Of Intranasal Midazolam, In Patients With Epilepsy
Upsher-Smith Laboratories, Inc., (Upsher-Smith) announced that Phase I data for USL261 (intranasal midazolam) in patients with epilepsy were presented at the American Epilepsy Society Annual Meeting in San Diego, CA.
-
Isis Announces Expedited Development Of ISIS-TTR Rx And Amendment To The Collaboration With GSK To Support Phase 2/3 Study
Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced today that Isis and GlaxoSmithKline (NYSE: GSK) have agreed to amend the clinical development plan and financial terms relating to ISIS-TTRRx to reflect the accelerated development plan for the drug. ISIS-TTRRx is an antisense drug in development with GSK for the treatment of TTR amyloidosis, a severe and rare genetic disease characterized by progressive dysfunction of peripheral nerves and/or heart tissue.
-
INC Research Discusses Benefits Of Involving CROs Early In Planning At Partnerships In Clinical Trials 2012
INC Research, LLC, a therapeutically focused global clinical research organization (CRO) with a Trusted Process for delivering reliable results, will discuss the importance of involving CROs early in the planning process at the Partnerships in Clinical Trials conference, November 6-9, 2012 at the CCH Congress Center in Hamburg, Germany.
-
Isis Pharmaceuticals Initiates Phase 1b/2a Study Of ISIS-SMNRx In Patients With Spinal Muscular Atrophy
Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced the initiation of a Phase 1b/2a study evaluating ISIS-SMNRx in children with spinal muscular atrophy (SMA).
-
Orion Receives Positive Phase II Study Results Of A New Levodopa Product For Parkinson's Disease
ODM-101, a new levodopa product currently developed by Orion for the treatment of Parkinson's disease, has successfully completed Phase II Proof of Concept trial. The key results indicate that ODM-101 was more efficacious than the reference product Stalevo® in the treatment of advanced Parkinson's disease patients. The study included more than 100 patients in Europe.
-
Bayer's Investigational Riociguat Meets Primary Endpoint In Phase III Study Of Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Bayer HealthCare today announced data from the Phase III CHEST-1 trial evaluating its investigational drug riociguat in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or with persistent or recurrent pulmonary hypertension (PH) after surgery.
-
Phase IIa Laquinimod Trial Results Show Positive Data For Potential Use In Active Crohn's Disease
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) today announced the presentation of Phase IIa clinical data for investigational laquinimod in moderate to severe Crohn's disease (CD).
-
Hybrigenics Starts Phase II Clinical Trial Of Inecalcitol In Chronic Lymphocytic Leukemia
Hybrigenics (ALHYG), a bio-pharmaceutical company listed on Alternext in Paris, with a focus on research and development of new treatments against proliferative diseases, recently announces the start of a phase II clinical trial of oral inecalcitol in patients with chronic lymphocytic leukemia (CLL).