DIA Biosimilars 2013

Technology Solutions

Marken launches SOLO to manage clinical trials distribution

Wednesday, December 7, 2011 12:53 PM

Marken has launched Solo, their proprietary web based system used to manage the regulatory, inventory and operational supply chain complexities of clinical trials. The system, which has been developed exclusively for Marken, is designed to manage all aspects of Marken’s global depot network including: receipt of clinical supplies and kits, dispatches, returns, warehouse movements and QA releases. Solo is a secure, validated, web-based system which is fully accessible to Marken’s clients on a 24/7 basis from any location in the world. Marken has designed Solo to integrate with multiple client-directed IXR (Interactive Reporting) systems.

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Cenduit: Now with Patient Reminders

HighQ partners with SAFE-BioPharma

Wednesday, December 7, 2011 12:23 PM

London-based HighQ has formed a vendor partnership with the SAFE-BioPharma Association. Companies within the global pharmaceutical and biotechnology industry use the SAFE-BioPharma standard in FDA Title 21 CFR part 11 compliant processes for signing SOPs, quality and compliance documentation, research and development documentation, corporate compliance documents and more.

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CRF Health – eCOA Forum

Almac launches COMPASS platform to improve clinical trial management

Wednesday, December 7, 2011 10:21 AM

Almac has launched of its new forecasting platform, COMPASS, which has been designed to improve the accuracy and efficiency of the supply inventory process during clinical studies. COMPASS provides benefits to clients by allowing the Supply Chain Manager to proactively direct the entire clinical supply chain, ultimately saving money that is often lost through inaccurate forecasting or overproduction of supplies.  

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DATATRAK named CDISC Registered Solutions Provider

Tuesday, December 6, 2011 01:28 PM
DATATRAK International has been recognized as a CDISC Registered Solutions Provider. DATATRAK has been registered as a CDISC consultant, system integrator and subject matter expert in the following CDISC standards: Clinical Data Acquisition Standards Harmonization (CDASH); Laboratory Data Model (LAB); Operational Data Model (ODM); Study Data Tabulation Model (SDTM).

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Healthcare Team Training, IDEAS launch StoryCare

Friday, December 2, 2011 11:55 AM

Atlanta, GA-based Healthcare Team Training and IDEAS based in Orlando, FL, have partnered to launch StoryCare, the first enterprise-wide, staff-deployed teamwork simulation program using the power of story to measurably improve
patient safety and satisfaction.

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Onconova extends agreement with BioClinica

Wednesday, November 30, 2011 02:54 PM
BioClinica has reported that Onconova Therapeutics has extended agreements using BioClinica Express electronic data capture (EDC) and data management services to support their clinical trials world-wide. Onconova has a number of clinical-stage products and a growing number of pre-clinical candidates. These development stage compounds are novel small molecules for the treatment of a broad range of hematologic malignancies and solid tumors.

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Lehigh Valley Health Network selects StudyManager's Reveal software

Monday, November 28, 2011 01:48 PM
Lehigh Valley Health Network has selected StudyManager’s Reveal software to manage its clinical trials.

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Roche, BGI develop advanced MHC technology

Monday, November 28, 2011 11:47 AM
Roche NimbleGen and BGI have developed a major histocompatibility complex (MHC) region capture technology based on NimbleGen SeqCap EZ Choice Library, a process for the enrichment of the MHC region. This newly developed approach allows easy capture and enrichment of these highly repetitive regions and enables the generation of deep sequencing coverage of the human MHC region. This new sample preparation approach overcomes the limitations of traditional methods of PCR and genomic enrichment used for disease and drug research. 

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PAREXEL advances early phase research technology

Tuesday, November 22, 2011 11:55 AM
PAREXEL International has enhanced its central nervous system (CNS)
capabilities for clinical development through the implementation of
functional magnetic resonance imaging (fMRI) technology in its Early Phase
units. This advanced imaging scanning measures hemodynamic response, or
change in blood flow, related to neural activity in the brain or spinal
cord. Through this approach, PAREXEL is able to provide sponsors with
improved testing paradigms for cognitive biomarkers and better understand
the impact of compounds earlier in disease progression.

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Savara joins SAFE-BioPharma

Tuesday, November 22, 2011 11:25 AM
Savara Pharmaceuticals, an inhalation drug development company, has joined SAFE-BioPharma Association. SAFE-BioPharma manages the SAFE-BioPharma digital identity and signature standard, used throughout the biopharmaceutical industry to verify and manage digital identities involved in electronic transactions and to apply digital signatures to electronic documents.

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September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

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The CenterWatch Monthly

October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

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September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

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