When Bruce Gillis, CEO of EpicGenetics, decided to look into fibromyalgia, he drew blood from 17 patients and analyzed 35 different immune system factors. When compared to a control group, he was astounded by the results. There was a huge disparity between the immune system markers for the 17 patients and those of the control group. That launched his quest for a cure.
For patients with sickle cell anemia, just getting through the day can be a struggle. Symptoms of the disease include vision problems, swelling of the hands and feet, and periodic episodes of pain that can last from a few hours to a few weeks. In this article Nick Leschly, CEO at bluebird bio, discusses the progress being made with its investigational gene therapy for sickle cell disease.
This is the first article in a two-part roundtable Q&A on real-world evidence (RWE) in the 21st century. In this first installment, we will explore common misconceptions surrounding real-world evidence (RWE), what should be considered to achieve good real-world data (RWD) analyses, and the impact this data can have on clinical treatment and regulatory development.
Over the last four years, the U.S. Medical Operations group of Novartis Oncology — in collaboration with internal clinical partners — has been transforming the study startup process for Novartis-sponsored studies.
As electronic research systems are increasingly relied upon to store participant data, report results, and confirm informed consent, regulatory bodies around the world are re-examining old regulations and developing new ones. Discover what it means for US research.
Automation is a foregone conclusion, and research sites need to prepare themselves for the electronic future that lies ahead.
Managing multiple outcome measures and rapid patient recruitment for Phase IIB clinical trial on targeting relapse-remitting Multiple Sclerosis
How a cloud-based SSU Solution with a SaaS-based platform manages the complexities of study activation.
Submission of PADERs to the FDA is required during post-marketing drug safety surveillance. Instill confidence in your results and regulatory submissions by partnering with an experienced partner.
PV activities will continue to grow in volume and complexity. Trusting an experienced partner to help manage PV requirements can free your team to concentrate on patient efficacy outcomes.
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With emerging and re-emerging infectious diseases the development of new anti-infectives and vaccines presents many challenges. We understand these challenges and our scientific experts can provide you with the strategic guidance to develop and validate custom assays and provide you with the high-quality laboratory services you need to ensure regulatory success.
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Access leading-edge technologies, scientific experts and Genomics Know-How®. Q2 Solutions | EA Genomics, advances science from understanding the human genome and disease biology to detecting the effects of therapies.
Medical and regulatory documentation developed by experienced medical writing teams plays a pivotal role in the success of a clinical research project.
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 (
