EDITOR'S DESK

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  “Virtual” Recruitment Roundtable: What Can Be Done With Social Media, Big Data?

  Social media and Big Data are two buzzwords in the clinical space that will influence recruitment practices in the future. In this segment of Clinical Leader’s “virtual” roundtable, our recruitment experts discuss the challenges that social media and Big Data bring to the industry and how pharma can begin to approach these trends to ensure successful trial recruitment.

• Pharma Outsourcing Trends: Industry Leaders, Equity Financing, And Vendor Consolidation
• “Virtual” Recruitment Roundtable: Keeping Clinical Trial Recruitment Timely
• TransCelerate Picks DrugDev To Develop Investigator Registry
• ACRES: Ready To Improve The Conduct And Quality Of Clinical Trials

CLINICAL PERSPECTIVES

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  The "State" Of Clinical Trial Contracts: What Pharma Sponsors Need To Know

  In an effort to garner varied data, sponsors institute clinical trials at various sites, including state agencies. This article will address clinical trial negotiation with a Connecticut state agency, but will also discuss salient issues that often affect entities of other states.  

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  Investigator Payments – Channels, Cycle Time and Benchmarks

  Considering the fair market value for investigator payments per trial costs is crucial in order to avoid higher payment which may result in financial strain on the sponsor. 

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  Just How Big Is Big Data?

  Despite all of this interest, a great deal of confusion remains around Big Data. Not only are there never-ending debates about what Big Data is, there's a huge range of possible Big Data solutions out there to choose from, only a few of which will be appropriate for any given situation or problem.

FROM THE INDUSTRY EXPERTS

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  Urinary Biomarkers Of Drug-Induced Nephrotoxicity

  Nephrotoxicity is a major reason for safety-related failures in drug development, often causing drugs to be withdrawn during late stages (phase2/3) of clinical development or even post-marketing. By Kamala K.Maddali, D.V.M., Ph.D., Harvey W. Kaufman, M.D., MBA, FCAP

• The BRCAvantage™ Test For Breast Cancer Clinical Trial Testing
• Next Generation Sequencing Technology In Oncology Drug Development
• Taking The “Risk” Out Of Risk-Based Monitoring

WHITE PAPERS AND CASE STUDIES

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  Dermal Toxicology: A Multifaceted Approach To Meet Today’s Research Needs

  Developing a dermal NCE generally follows the same path as other small molecule NCEs administered orally or systemically, except that the dermal route is used in a non-rodent model.

• Electronic Informed Consent: Considerations For Implementation In Clinical Trials
• Top Clinical Research Trends of 2014
• HIV1 Genotypic Tropism Assay
• Innovative Testing Solutions For Patient Stratification In Relation To Lung Cancer Trial Recruitment

INDUSTRY NEWS

• CRF Health Patient-Centric eCOA Solution To Support Flexibility And Compliance In Global Diabetes Trials

  CRF Health, the leading global provider of eCOA solutions for the life sciences industry, recently announced a complete TrialMax eCOA solution for diabetes clinical trials.

• Pluristem And Hadassah Medical Center Announce Significant Data Showing PLX-R18 Cells Improve Bone Marrow Transplantation
• CEL-SCI Reports 2nd Consecutive Month Of Record Patient Enrollment In 2015 For Its Phase III Head And Neck Cancer Trial
• Exostar & DocuSign Partner To Help Life Sciences And Healthcare Organizations Go 100% Digital
• Alizé Pharma Launches Phase II Clinical Trial Of AZP-531 In Prader-Willi Syndrome

FEATURED SERVICES AND PRODUCTS

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  Quality Assurance Service: Investigation Trials & Postmarketed Projects Phase I-IV

  The function of Chiltern's independent QA auditing group is to assess, for investigational trials or postmarketed projects (Phases I-IV), the state of compliance with ICH-GCP and/or applicable regulatory requirements, Standard Operating Procedures (SOPs), the study protocol and/or project plans.

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  Observational Research

  Increasingly, health authorities, insurers, regulators, policymakers, physicians and patients are all seeking information to better understand “what works” in the real world; that is, in settings that reflect how diseases are treated and how clinical products are actually utilized without the controls and constraints of traditional clinical trials.

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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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  Late Stage Clinical Product Development Strategy

  Our deep expertise in translational and clinical sciences combined with strong operational background allows us to evaluate each client's assets as unique commercial opportunities. We guide our clients through critical strategic decisions at product transition points, and help them manage partnerships or other collaborative alternatives.

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  CoSign Digital Signatures

  Strict regulations, such as the FDA's 21 CFR part 11, require organizations in the life sciences industry to guarantee the authenticity, integrity and confidentiality of electronic records.

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  eClinical OS Trial Connect Mobile App

  Access your trials virtually anywhere, at any time. Critical study data – now at your fingertips.

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  BioClinica Supplies Optimizer

  Modern clinical trials require sophisticated planning. Global logistics, complex trial designs, and delicate investigative compounds are just a few of the factors that make accurate clinical trial supply management a difficult task.

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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

• 03.04.15 -- Clinical Leader Newsletter: The Keys To Effective Strategic Partnerships
• 03.02.15 -- Clinical Leader Newsletter: ACRES Ready To Improve Conduct & Quality Of Trials
• 02.25.15 -- Clinical Leader Newsletter: TransCelerate & DrugDev Form Investigator Partnership
• 02.23.15 -- Patient Recruitment For Personalized Medicine Oncology Studies
• 02.18.15 -- 21st Century Cures Ready To Revolutionize Pharma