FEATURED ARTICLES

Speeding Research With Data Mining Expertise Speeding Research With Data Mining Expertise

According to The STM Report (2015), more than 2.5 million peer-reviewed articles are published in scholarly journals each year. PubMed alone contains more than 25 million citations for biomedical journal articles from MEDLINE. The amount and availability of content for clinical researchers has never been greater – but finding the right articles to use is becoming more difficult.

  • Santosh Vetticaden
    A Chief Medical Officer's Perspective On Selecting A CRO

    Santosh Vetticaden, Ph.D., M.D. is a drug development professional with over 20 years of experience spanning large pharma and biotech across multiple therapeutic areas. He has been involved in trials from Phase I-Phase IV and has been extensively involved in the design, planning, and implementation of global trials. By Rob Wright, Chief Editor, Life Science Leader magazine

  • Effective Medical Writing And Preparation For A Successful Clinical Submission In 2007, the FDA released draft guidance to the industry pertaining to governance, compliance, safety, effectiveness, substantial and certifiable equivalence data included in clinical submissions. By Dr. Diane Mauriello Ph.D., Dante Resouces, Inc.
  • Post Market Reporting And The Use Of Terminologies: MedDRA And WHO-DD. The pharmaceutical Industry is ever changing with novel drug development and research. The use of pharmaceutical products is carefully regulated from the initial submission of an Investigational New Drug application to the reporting of adverse events once the drug has been marketed. By Samina Qureshi, M.D., PSI International, Inc.
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WHITE PAPERS & CASE STUDIES

  • Signature Requirements For The eTMF

    Sponsors and CROs want to ensure that the processes and workflows they use in their electronic Trial Master Files (eTMF) comply with all regulatory requirements, resulting in a robust system that will produce complete documentation able to withstand an agency audit. To provide a solid basis for decision-making, we’ve researched both the regulatory basis for signatures and the technology implications around how to collect signatures. Since the goal of any eTMF system is to streamline processes and increase compliance, implementing valid signature processes in the least cumbersome manner is always of concern.

  • Therapeutic Expertise: Neuroscience & CNS Datasheet PRA is a leader in the clinical research industry, providing innovative solutions for CNS drug development.
  • Endocrinology Services Brochure A leading western CRO in Russia, ClinStar offers invaluable experience and strong medical backgrounds 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 endocrinology.
  • White Paper: Foreign Clinical Trial Data Given the high cost of moving a promising drug candidate through years of clinical trials, it’s no wonder that more and more drug manufacturers have begun conducting at least some of their clinical trials in foreign countries. With lower costs and shorter recruiting times, the use of foreign sites is appealing to all drug developers, but especially to those involved in generic and “fast-track” approval programs.
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SERVICES & PRODUCTS

Medical & Regulatory Affairs

Taking new products successfully through clinical development, submission and approval can be a difficult, expensive and lengthy process. SynteractHCR’s medical regulatory affairs group offers a wide range of services that spans the full range of product development, including training, performed by senior regulatory professionals with experience in pharmaceutical, diagnostic, device and biotechnology industries. Our medical regulatory affairs team is here to deliver on aggressive timelines and control costs, while ensuring compliance and patient safety.

Medical Writing

As an international, full-service clinical contract research organization, SynteractHCR strives to deliver actionable results for your clinical trial needs. Our medical writing group consists of qualified Ph.D., M.D., and other experts, and our European medical writers are all members of the European Medical Writers Association. Our translation team consists of native speakers with many years of experience in translating all documents necessary for the performance of clinical studies. Our medical writers are committed to delivering a well-designed clinical program that will meet your study’s ultimate goals.

Adverse Event Management

At Sentrx, we run the gamut, covering every aspect of pharmacovigilance for all stages of development and all sizes of clients. Whether your circumstances are more heavily influenced by clinical needs or post-marketing surveillance requirements or you are examining drug safety as part of your New Drug Application planning or preparing to implement risk mitigation strategies, Sentrx has the expertise to make your drug safety operations more flexible, cost-effective, and efficient.

DESI (Drug Efficacy Study Implementation) Drugs Approval
Camargo will work with you to prepare a comprehensive plan to secure approval for DESI (Drug Efficacy Study Implementation) drugs.
505(b)(2): Is it for you?
A 505(b)(2) is a new drug application which contains full safety and effectiveness reports, but allows at least some of the information required for approval to come from studies not conducted by or for the applicant.
Regulatory Affairs

Our team of Regulatory Affairs experts plays a pivotal role in your project from initiation to completion, ensuring compliance with applicable laws and regulations throughout the process.

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NEWS

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