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  • Biopharma Trends That Will Impact The Industry In 2016
    Biopharma Trends That Will Impact The Industry In 2016

    The beginning of the year is always a good time to take a look ahead at the trends most likely to impact the industry in the coming months. One area that is changing quickly, and which promises to impact clinical trials in the coming years, is biopharma. I recently spoke with Jim Esinhart, CEO of Chiltern, about some of these trends, including study protocols, big data, mergers, and new technologies.

  • What You Need To Know About FDA’s Clinical Outcome Assessment Compendium
    What You Need To Know About FDA’s Clinical Outcome Assessment Compendium

    One of the goals of CDER (The FDA’s Center for Drug Evaluation and Research) is to foster patient-focused drug development. As part of that effort, the agency has published a compendium of clinical outcome assessments (COAs) to promote the use of patient-focused outcome measurement in the drug development process.

  • Home Clinical Trial Visits – A Patient Centric Solution
    Home Clinical Trial Visits – A Patient Centric Solution

    The continuing rise of patient-centricity within the drug development industry is a crucial consideration for sponsors when designing their clinical development plans. With initiatives such as the FDAs Patient-Focused Drug Development Program, patient experience and voice within a clinical trial is becoming increasingly important.

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  • Phase I-IIA Clinical Trials Brochure

    At inVentiv Health we have the ability to expedite clinical programs and build the foundation for continued development of the product.

  • Regulatory Approval Of Clinical Studies In The Netherlands
    Regulatory Approval Of Clinical Studies In The Netherlands

    The EU Clinical Trials Directive (CTD) has been fully implemented in the Netherlands. 

  • Advances In Electronic Data Capture Of Medical Data
    Advances In Electronic Data Capture Of Medical Data

    Electronic Data Capture (EDC) refers to the collection of medical data for patients enrolled in clinical trials. The most common mechanism is for staff at the investigative site to enter the data into a web-based interface, and for staff at the sponsor company to monitor the data using the same interface but with different security permissions. By Keith Howells

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Clinical Operations Clinical Operations

Clinical operations are a critical component in all studies. SynteractHCR’s highly skilled staff is well-versed in clinical trial operations including implementing, monitoring and managing the clinical components of a study. From start-up to close-out, experienced clinical managers and clinical research associates (CRAs) oversee each study’s clinical processes to ensure proper planning, conduct, patient safety, and data quality, while fostering good communication between study sites and sponsor.

Biostatistical Services Biostatistical Services

Delivering high-quality and accurate data analysis, SynteractHCR is a contract research organization that provides robust and customized biostatistical services tailored to your study’s needs. At SynteractHCR, we believe that a statistician is a vital component in the clinical development process. Working as your partner, SynteractHCR’s expert biostatisticians will review your study’s needs and determine the best methods for collecting, analyzing and presenting your data, all in compliance with regulatory guidelines. Our team is trained to provide creative thinking and analysis optimized for your unique study designs. We provide access to your data in a format well-suited to your project requirements.

Phase IIb-III Clinical Trials Phase IIb-III Clinical Trials

With decades of experience in clinical trial design, inVentiv Health offers a full range of clinical trial services including bioanalysis, biostatistics, data management, feasibility studies, global safety and pharmacovigilance, medical writing, project management, protocol and case report form design, quality assurance, regulatory affairs, risk management, site management, strategic planning, and study monitoring.

Merge CTMS For Investigators Merge CTMS For Investigators

Through enhanced productivity and business management tools, Merge CTMS for Investigators allows research organizations to centralize study information, organize research activities, and improve recruitment and financial performance.

Clinical Trial Feasibility Clinical Trial Feasibility

Delays in research have significant time and cost implications and negatively impact an organization, regardless of size or financial stability. The potential for delays can be decreased or mitigated through comprehensive planning.

Oncology Services Oncology Services
A leading western CRO in Russia, ClinStar offers invaluable experience to enhance your study execution, resulting in higher-quality results. We offer local regulatory, customs and logistical expertise, as well as clinical teams that are therapeutically trained in oncology.
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