EDITOR'S DESK

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  Pharma, Mobile Health, And Patients: How Stakeholders Can Better Advance Clinical Trials

  Clinical trials are evolving. The cost, along with issues surrounding patient recruitment and retention, are forcing many sponsors and CROs to rethink the conduct of trials. One innovation that will certainly have an impact will be mobile health technologies.  

• Will Genomics Complicate The Reanalysis Of Randomized Clinical Trial Data?
• Cell Thawing: Are You Risking GMP Compliance With The Water Bath Method?
• Challenges In The Reanalysis of Randomized Clinical Trial Data
• How To Develop Patient-Centric Clinical Trials In The Internet Age

CLINICAL PERSPECTIVES

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  Single Molecule Measurement: Best Practices In Biomarker Detection

  By Mark Roskey, Vice President and General Manager, Applications and Reagents 

  The human genome encodes thousands of secreted proteins, each of which is an actor in the delicate biochemical balance of diagnostics. Even a slight change in any one of these proteins can mean the difference between sickness and health. Such a change also provides a critical window into the body and helps to direct diagnosis and treatment, however, the vast majority of secreted proteins are present in concentrations well below what conventional technologies can measure, and their role in human health is poorly understood. Researchers have continued to seek ways to detect and diagnose earlier and more accurately through protein detection, and have been unsuccessful at doing so – until now.

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  Intent To Treat Enrichment: A Solution For Better Clinical Trials Of Precision Cancer Medicines

  As cancer medicine increasingly targets specific molecular abnormalities, more of the anticancer drugs in clinical trials are precision medicines, intended to treat a highly selected niche population of patients.  The opportunity for better treatment creates not only a proposition of needles and haystacks, but of hundreds of different kinds of needles sprinkled through thousands of haystacks. 

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  BRIC Nations: Divergent Patterns in the Clinical Trials Landscape

  The clinical trial landscape in BRIC countries is changing. Long heralded as a low-cost alternative to Western markets, Brazil, Russia, India and China are experiencing a shift in trial initiation by global sponsors.

FROM THE INDUSTRY EXPERTS

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  Taking The “Risk” Out Of Risk-Based Monitoring

  The clinical trial landscape is continually evolving and with it, efforts in the improvement of participant safety and data integrity. CROs are beginning to transition from on-site monitoring, with 100% point-to-point source data verification, toward a risk-based monitoring (RBM) approach that utilizes source data review and more centralized monitoring techniques better adapted for mitigating risk. 

  While RBM has gained considerable attention in recent years, reluctance still remains around the approach—from uncertainty arising from the use of “risk” employed in its name to sponsors being wary of potential implications on data quality and regulatory inspection outcomes.

• Conducting Early Phase Trials In Schizophrenia
• You’ve Gone This Far, Now Complete Your TMF
• Adaptive Trials: A Design For Life

WHITE PAPERS AND CASE STUDIES

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  From Cold To Controlled

  World Courier Ground Europe reveals impressive test results for new fleet of temperature-controlled vehicles.

• Reduce Risk And Raise Quality In Clinical Trials
• EDC Versus Paper – A Head To Head Comparison
• The Role Of Observational Research And Patient Registries In Evidence Generation
• Meeting Enrollment Goals: Problem-Solving Leads To Early Completion Of Breast Cancer

INDUSTRY NEWS

• Ascendis Pharma A/S Announces Pricing of Initial Public Offering

  Ascendis Pharma A/S (Nasdaq: ASND), a clinical stage biopharmaceutical company, today announced the pricing of its initial public offering of 6,000,000 American Depositary Shares (ADSs).

• eClinicalOS v2015.1.0
• Three West Coast Biotechs Standardize On BioClinica
• Actinium Submits CMC Meeting Request To FDA For Iomab-B To Support IND Filing And Anticipated Commencement Of Phase 3 Trial In Mid-2015
• Covance Launches New Solution To Bridge Preclinical To Clinical Development

FEATURED SERVICES AND PRODUCTS

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  Greenbox Reusable Thermal Packaging

  Greenbox is the industry’s first and only completely sustainable and reusable thermal management system for cold chain transportation. Created from 100 percent organic-based materials, Greenbox reusable thermal packaging materials are non-toxic, fully biodegradable and suffer no thermal degradation after more than 20,000 uses.

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  Electronic Data Capture (EDC) Services

  As experts in electronic data capture our solutions are designed to integrate into everyday lives through simple, easy to use diaries, questionnaires and assessments delivered to the patients’ own devices.

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  GMP Compliance

  Deficiencies in QMS systems in general and the CAPA process in particular make up a significant portion of FDA 483s (documented findings reported from FDA inspections) and warning letters.

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  Phase IV

  Understanding the reasons behind product success in a clinic setting and the marketplace is essential. Worldwide Clinical Trials specializes in the design of peri-approval studies focused exclusively on this issue. After evaluation of the study objectives we create a study tailored to your needs, enabling you to consider drug efficacy in treating additional indications, support promotion claims through publication data or evaluate your product against a competitor.

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  Biopharm & Medical Device Vendor Management

  In today's environment, companies are focusing on optimizing costs and as such, utilize external vendors frequently. However, with organizations increasingly dependent on multiple vendors to support product development, a disciplined approach to vendor management is critical for success.

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  Merge eClinical OS™

  Merge eClinical OS™, our flagship product, is a truly unified platform designed to help clients manage and run studies faster and more cost effectively.

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  Site Intelligence & Activation

  Our industry is faced with lengthened development timelines, increased costs and the need for greater global harmonization and planning across development functions. These changes have also brought increased regulatory challenges and cost pressures. Consequently, PPD’s study start-up process has rapidly evolved over the past five years to address these challenges and increase global coordination and consistency.

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  Ensuring Cold Chain Remains Cold And Control Room Temperature Remains Controlled!

  Qualification testing for the newest additions to the World Courier Ground Europe suite of vehicles has just been completed at Cambridge Refrigeration Technology (CRT) and the results are looking very impressive.

CLINICAL LEADER WEBINARS

• Advancing Research In Skin Biology with Metabolomics

  This 30-minute webinar demonstrates how metabolomics can be a powerful tool in dermatological and skincare research.

• Leveraging Metabolite Biomarkers For Clinical Trials

  This 30-minute webinar will introduce a robust, highly sensitive biomarker development program that leverages a revolutionary metabolomics discovery platform to improve the range of analytes that can be measured routinely and reliably.

• Tapping The Metabolome For Answers- A State Of The Art Approach

  This 30-minute webinar provides a brief overview of recent advances in metabolomics technology and methodology, which together have advanced the field of metabolomics.

• Strategic Considerations For Implementing A Regulatory Document Management System

  Regulatory content across a product lifecycle is abundant, cumbersome, and absolutely critical to both the product and organization's success.  It ensures both corporate and agency compliance and proves accountability.  

ARCHIVE NEWSLETTER

• 01.28.15 -- Clinical Leader Newsletter
• 01.26.15 -- Getting The Right Drug To The Right Patient At The Right Time
• 01.21.15 -- Lilly Moves From Patent Expirations To New Product Growth
• 01.19.15 -- How To Develop Patient-Centric Clinical Trials In The Internet Age
• 01.14.15 -- Taking The "Risk" Out Of Risk-Based Monitoring