EDITOR'S DESK

CROs In A Business Exchange With Silicon Valley?

As an applied economic theoretic, by driving out inefficiencies from the current model used by researchers to find and contract with CROs, the Science Exchange should improve the business model for drug discovery. But will all parties — Pharma/Bio, CROs and individual researchers — benefit equally? 

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CLINICAL PERSPECTIVES

  • Prioritizing The BioPharma Portfolio – Get The Right Assets On The Bus (and The Wrong Ones Off)
    Prioritizing The BioPharma Portfolio – Get The Right Assets On The Bus (and The Wrong Ones Off)

    Everyone is looking for the silver bullet: the product that will change the face of biopharmaceuticals and draw blockbuster revenues. If you have one of these, you can stop reading. But if you are like most companies, your portfolio is a mix of some winners, some underachievers, and a lot of “in-betweeners.” The process of getting the right assets on the bus (and funded) in a cash-strapped environment is as much an art as a science. As consultants to the industry for many years, we’ve seen myriad processes – both good and bad. 

  • Understanding Key Early Phase Clinical Trial Cost Drivers
    Understanding Key Early Phase Clinical Trial Cost Drivers

    Pharmaceutical companies have been implementing intensive cost–saving efforts in the recent years through mergers, reducing overheads, and trimming down of entire business units for efficiency. These efforts have increased the need to outsource services to external vendors throughout the R&D value chain. The early phase clinical trial market in 2014 saw an approximate outsourcing rate of 56 percent with most of the patient studies being externalized to both global and specialist CROs. As cost efficiency is the main focus for pharma, it is important to understand the cost behavior of outsourcing services.

  • Microbiome Research: The New Horizon In Therapeutic Value Creation
    Microbiome Research: The New Horizon In Therapeutic Value Creation

    There are many potential causes of microbial imbalance (dysbiosis) in adulthood, including repeated and inappropriate exposure to antibiotics in earlier years, alcohol misuse, or an inappropriate diet.  Balancing the intestinal microbiome is a logical approach to preventing or reversing diseases caused by dysbiosis. 

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FROM THE INDUSTRY EXPERTS

  • Value Takes Center Stage Amid Excitement Over New Data At Annual Oncology Meeting In Chicago
    Value Takes Center Stage Amid Excitement Over New Data At Annual Oncology Meeting In Chicago

    The world’s leading cancer experts gather today in Chicago for the American Society of Clinical Oncology 51st meeting to explore topics in one of healthcare’s most complex and rapidly evolving therapeutic areas.

    It’s too early to say if there will be any big surprises this year, but looking over the weekend’s schedule, it is obvious that the conference discussion will largely center around pharmaceutical companies developing and launching novel immunotherapies that are changing the landscape in cancer care. This year’s conference also will highlight the companion topics of precision medicine and predictive diagnostics for finding the right patients for these advanced and costly treatments.    

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WHITE PAPERS AND CASE STUDIES

  • Deploying Mobile Devices Globally Streamlines Clinical Trial Process
    Deploying Mobile Devices Globally Streamlines Clinical Trial Process

    Traditionally, clinical trials are paper-based. Patients use written responses to questions and track their daily medical experiences in a written diary. Beyond the awkwardness and inconvenience, when it comes time to aggregate results from all patients to assess results, the manual process of data assembly is time-consuming and prone to errors.

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FEATURED SERVICES AND PRODUCTS

  • Clinical Diagnostic Services
    Clinical Diagnostic Services

    PRA specializes in developing comprehensive and cost-effective solutions for all phases of diagnostic research: discovery, development, validation, and commercialization/ reimbursement.

  • CNS Clinical Research
    CNS Clinical Research

    Worldwide Clinical Trials is an innovator in the field of CNS clinical research. Our clinicians, scientists and management team have tremendous understanding of psychiatry, neurology and analgesia drug development.

  • Strategic Resourcing Functional Services
    Strategic Resourcing Functional Services

    Our dedicated functional teams have the experience to be your partner in clinical research. We deliver a variety of clinical development services customized to fit your objectives, whether you need a single function across several drug programs, a range of functions within a single therapeutic area, a complete staff lift-out or any other defined need.

  • Patient Reminders™: Reduce Site Burden and Motivate Patients
    Patient Reminders™: Reduce Site Burden and Motivate Patients

    Automated, personalized SMS text messages, emails, calendar alerts, and voice messages can help patients stay on track with the clinical trial protocol by improving patient adherence, compliance, and retention. 

  • Early Patient Clinical Studies
    Early Patient Clinical Studies Acquire robust Proof-of-Concept (PoC) data for your targeted populations with the Covance Early Clinical Development (ECD) specialists. The very nature of PoC studies requires cultivation to tease out excellences.
  • Electronic Data Capture (EDC) Services
    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.

  • UX Trial Design™ - Unified Design Tool
    UX Trial Design™ - Unified Design Tool

    DATATRAK ONE® UX Trial Design™ product streamlines the entire design-to-deployment process using a single tool. Trial Designers are able to configure their studies, immediately view their changes in the Design environment and commit the files into the versioning repository.

  • Consulting
    Consulting Clinical trials involve a myriad of complicated processes and variables. Rho can help you navigate the clinical trial process to save you time and minimize costs.
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CLINICAL LEADER WEBINARS

  • An Intelligent Approach to Risk-Based Monitoring

    How People, Process and Tools can Improve Clinical Trial Quality

  • Synergism: Partnering on EDC Technology Transfer

    Join this webinar and hear about different EDC sourcing models − the traditional EDC software approach and EDC technology transfer – and find out what level of control in studies is right for you.

  • RBM-Enabling Technology: Analytics with Action

    In this webinar participants will explore technology considerations in depth with Trevor McCaw, co-developer of BioClinica's Compass intelligent monitoring solution. Trevor will explain how to tell if an RBM tool is truly framed around risk and quality principles using Compass as a demonstration platform.

  • Modern Randomization: A Sampling of Current Schemes using IRTs

    Patient randomization is critical to running all blinded clinical trials, but not all randomization methods can meet the needs of modern studies. Complex protocols that include multiple treatment arms, adaptive designs, and inconsistent allocation ratios require advanced interactive response technology (IRT) randomization engines for proper trial execution. This increased statistical power brings with it a higher risk of error and can impact drug supply predictability, making it more important than ever to find the right IRT system for your trial.

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FIND A CRO IN SOUTHERN CALIFORNIA

find a cro in drug development

Find a CRO with BIOCOM’s drug development guide which provides a description of each phase along with a list of companies that can accommodate your needs in the drug development cycle.

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 UPCOMING TRAINING COURSES

Pediatric Clinical Trials: Special Considerations and Requirements

June 1, 2015
2pm-3:30pm EDT, Online Training

FDA GMP Inspections – Proven Preparation & Survival Techniques

June 2, 2015
1pm-2:30pm EDT, Online Training

Cost-Efficient/Cost-Effective Validation Protocols

June 3, 2015
1pm-2:30pm EDT, Online Training

Identifying and Closing the Training Gap in Clinical Research

June 9, 2015
1pm-2:30pm EST, Online Training
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CLINICAL BULLETIN BOARD

According to the WHO, over 150m people worldwide, are chronically infected with HCV, with 3 to 4m new infections occurring each year. Together they represent a multibillion dollar market for any successful new drug candidate, with Hepatitis C having the most promising products in development.

 CLINICAL EVENTS

Pediatric Clinical Trials: Special Considerations and Requirements

June 1, 2015
2pm-3:30pm EDT, Online Training
Price:  $299 - Introductory Rate

CHI's Clinical Trial Oversight Summit

June 1, 2015
Boston, MA

FDA GMP Inspections – Proven Preparation & Survival Techniques

June 2, 2015
1pm-2:30pm EDT, Online Training

Cost-Efficient/Cost-Effective Validation Protocols

June 3, 2015
1pm-2:30pm EDT, Online Training
Price:  $299

Reacting to “Human Error” – Moving Beyond “Retraining” As A Response

June 4, 2015
1pm-2:30pm EDT, Online Training
Price:  $299 - Introductory Rate
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