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.

  • Start Planning Your Clinical Trials NOW

    Most entrepreneurs new to drug development are focused on demonstrating the pharmacology of their compound, and rightfully so. There is no point in spending years and millions of dollars in the development of something that does not have a chance of demonstrating efficacy in a clinical trial. Often, however, too little planning is done to position the investigational compound as an actual drug for the treatment of human disease.

  • Increased Adoption Of iPSC-Derived Human Cells For Use In Drug Discovery And Toxicity Testing

    Traditionally, discovering a pharmacological therapy for a disease involves first investigating the underlying biological processes of that condition and then identifying drug candidates that interfere with those processes.  From here, the most promising compounds are advanced to pre-clinical and clinical development. The goal of this “bench to bedside” approach is to translate bench research to point-of-care patient outcomes as quickly and safely as possible. With dwindling drug pipelines, pharmaceutical companies need new approaches that can re-energize their discovery efforts. By Chris Parker, Vice President and Chief Commercial Officer, Cellular Dynamics International

  • rob
    Drug Approval Process A Challenge To Manage In the United States, the drug submission approval, and review process is very complicated, with many facets, including manufacturing, preclinical, clinical, and safety. Dr. Paul Chew should know, as he is the chief science officer (CSO) and chief medical officer (CMO) for Sanofi U.S. By Rob Wright, Chief Editor, Life Science Leader magazine
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WHITE PAPERS & CASE STUDIES

  • Regulatory Approval Of Clinical Studies In The Netherlands

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

  • 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.

  • Pharmacovigilance Monitoring Services Norwich Clinical Services offers comprehensive pharmacovigilance services for pre-marketing product safety, post-marketing surveillance and data analysis.
  • Human ADME & Studies With Radiolabeled Compounds

    During clinical drug development there can be several situations where the use of radiolabeled medication or other radiolabeled compounds is required or favorable to accomplish the study objectives. This whitepaper is mainly focusing on human ADME studies and “microdose” studies to assess absolute bioavailability (BA). The major part of the information in this overview is also relevant for other clinical studies with a radiolabeled compound. By Ad Roffel and Henk Poelman, PRA Health Sciences

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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.

Marketing Application Submission Services

Biopharmaceutical companies’ marketing applications must present the history of their unique development programs and provide renewed hope for patients seeking safe and effective therapies. PRA Health Sciences has the necessary experience to deliver comprehensive marketing applications (NDA, BLA, MAA, etc) across all therapeutic areas and in all regions.

Clinical Product Safety

Given the complex nature of medicines and the associated unpredictability of adverse events, pharmacovigilance activities play a critical role in managing the risks posed to the general population.

Pharmacovigilance

It's peace of mind -- and more. Global Safety AdvantageSM is an enhanced and seamless Global Safety Surveillance and Pharmacovigilance program.

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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