Theorem Clinical Research

Study Conduct

Rare Cancers Europe calls for new criteria to be used in clinical trials

Thursday, October 2, 2014 02:26 PM

A consensus paper by Rare Cancers Europe (RCE) calls for new methodologies to be applied to clinical studies in rare cancers. RCE—a multi-stakeholder initiative representing patient associations, medical societies and industry—is calling both the community of researchers and European authorities to address research methodologies and regulatory criteria that could limit rare cancer patient access to new therapies. This would mean discrimination against this patient population.

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Quest Diagnostics

Clinical Conductor CTMS, OpenClinica EDC partner

Wednesday, October 1, 2014 01:17 PM

Clinical Conductor CTMS, a Rochester, N.Y.-based provider of clinical trial management system, and OpenClinica, a Waltham, Mass.-based provider of global electronic data capture (EDC) software platforms, have partnered to deliver a seamless EDC-CTMS integration to drive productivity in clinical research.

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Radiant/CRA enrolls 8,000 in hepatitis B vaccine study

Friday, September 26, 2014 03:23 PM

Radiant Research/Clinical Research Advantage (CRA), a Tempe, Ariz., wholly owned clinical trial site management organization, has completed enrollment for the Dynavax Technologies phase III clinical trial of HEPLISAV-B, an investigational adult hepatitis B vaccine.

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Tekmira joins consortium conducting Ebola virus trials in West Africa

Wednesday, September 24, 2014 01:22 PM

Tekmira Pharmaceuticals, a British Columbia-based developer of RNA interference (RNAi) therapeutics, is collaborating with an international consortium to provide an RNAi-based investigational therapeutic for expedited clinical studies in West Africa.

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Navidea awarded $1.67M to evaluate Lymphoseek for cervical cancer

Wednesday, September 24, 2014 01:20 PM

Navidea Biopharmaceuticals, a Dublin, Ohio developer of precision diagnostics and radiopharmaceutical agents, has received an initial notice of award for a Fast Track Small Business Innovation Research (SBIR) grant providing for up to $1.67 million from the National Cancer Institute (NCI), a part of the NIH, to fund evaluation of Lymphoseek (technetium Tc 99m tilmanocept) Injection in women with cervical cancer.

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Survey: Remote eTMF access to double in 2015

Monday, September 22, 2014 02:30 PM

There has been an increase in the number of clinical trial sponsors that plan to provide auditors with remote access to their electronic trial master file (eTMF), a life sciences industry TMF survey revealed.

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Lupus Research Institute holds NYC's first Lupus Trials Fair

Monday, September 15, 2014 12:39 PM

Over 200 patients, families, physicians and scientists came together under one roof last Friday, Sept. 12, to learn, interact and participate in the drive for better lupus treatments at New York City's first Lupus Trials Fair, launched by the Lupus Research Institute (LRI) and the S.L.E. Lupus Foundation.

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Trialbee helps AstraZeneca reduce recruitment time of patients to clinical trials

Monday, September 15, 2014 12:38 PM

Swedish e-health company Trialbee has signed a professional service agreement with AstraZeneca for e-recruitment.

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Medidata, Icon partner to bring efficiencies to ePRO

Thursday, September 11, 2014 01:40 PM

Medidata, a NewYork-based global provider of cloud-based solutions for clinical research in life sciences, and global CRO Icon have formed a joint initiative designed to bring new efficiencies to the administration of electronic patient-reported outcomes (ePROs) in clinical trials. The new offering provides sponsors with an ePRO solution that reduces costs, saves time and enhances patient engagement.

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PMG Research forms its 11th clinical site

Wednesday, September 10, 2014 03:07 PM

PMG Research (PMG), an integrated network of clinical research facilities in the southeastern U.S., has established its 11th clinical research site, PMG Research of Rocky Mount. PMG Research has assumed ownership and operation of the clinical research department at Boice-Willis Clinic in Rocky Mount, N.C., further expanding PMG’s presence in eastern North Carolina. This new site enhances PMG’s access to an additional 130,000 patients.

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AiCure
CWWeekly

March 30

Icon, Carnegie Mellon partner to research ways to improve study patients' understanding of Informed Consent

Veeva launches OpenKey, partner program to unlock difficult access to, restrictions on customer reference data

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The CenterWatch Monthly

March

Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

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The CenterWatch Monthly

February

Study grants market breaks $13 billion
Volume of clinical activity rising while growth in grant spending slows

Revisiting eClinical Technology Solutions Adoption
While use of established solutions grows, sponsors hesitate on newer tools

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