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FEATURED ARTICLES

  • Clinical News Roundup: Biopharm Seeks More FDA Input On Endpoints
    Clinical News Roundup: Biopharm Seeks More FDA Input On Endpoints

    Clinical News Roundup for the week of March 19, 2017 with information on FDA, NIH, clinical trial applications, pharma’s reputation, and an algorithm to make trials safer and less costly.

  • AstraZeneca Strives For Greater Trial Transparency
    AstraZeneca Strives For Greater Trial Transparency

    In February 2017, trial transparency provider TrialScope announced the launch of its Trial Results Summaries Portal that was developed in partnership with AstraZeneca. The Portal is a publicly accessible website where clinical trial sponsors can inform and educate trial participants and the general public about trial results in a non-promotional and non-biased venue.

  • How Will Changes At FDA Impact Clinical Trials?
    How Will Changes At FDA Impact Clinical Trials?

    The 21st Century Cures Act has been approved by both the House and Senate, and late last year was signed into law by President Obama. The 996-page bill includes changes to the way FDA regulates drugs, medical devices, and biologics. In 2017, we have seen a change in administrations and will likely see a change in leadership at the FDA. I took this opportunity to touch base with David Rosen, co-chair of the life science practice at Foley & Lardner LLP and a law practice consultant. In this Q&A, Rosen shares his thoughts on the new legislation, changes coming to FDA, and why the patient perspective needs to remain a primary concern of the drug development industry.

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WHITE PAPERS AND CASE STUDIES

  • Avoid Wasted Trials: One Story Of An Estimated $100M Saved
    Avoid Wasted Trials: One Story Of An Estimated $100M Saved

    The complexity of clinical trials continues to rise. New biomarkers for safety and efficacy continue to emerge, and new types of information – like genomic profiles – have become critical to submissions for drug approval. Against this dynamic backdrop, the central challenge facing trial sponsors is the need to bring together diverse data sets, draw meaningful insights from them and act quickly to maximize return on investment.

  • A Comprehensive Named Patient Programme (NPP) That’s Adaptable To Expansion
    A Comprehensive Named Patient Programme (NPP) That’s Adaptable To Expansion

    Challenge: A biotech company launched a Named Patient Programme (NPP) that required complex and dedicated operational support. The NPP demanded expedited patient eligibility review and urgent drug shipment to an extremely sick patient population. High patient demand from a global population encouraged them to seek a pharma services provider to manage the programme.

  • Does ICH E6 R2 Effect Risk-Based Monitoring And Overall Quality Risk Management?
    Does ICH E6 R2 Effect Risk-Based Monitoring And Overall Quality Risk Management?

    Regulators are encouraging the industry to take a new quality risk management (QRM) approach to clinical trial execution. The latest International Council for Harmonisation (ICH) Good Clinical Practice (GCP) E6 R2 guidelines represent the first update to the guidelines in over 19 years.

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SERVICES AND PRODUCTS

Clinical Trials Feasibility And Clinical Informatics Services Clinical Trials Feasibility And Clinical Informatics Services

At inVentiv, our ultimate goal is to improve the planning and execution of clinical trials in a cost-effective and timely manner.

Rare Disease And Orphan Drug Research Rare Disease And Orphan Drug Research

While developing drugs to treat rare diseases is more viable from a business perspective than ever before, the clinical research and go-to-market planning process is still fraught with challenges. Regulations, protocols, logistics, and reporting are all different when patients are scarce, the stakes are high, and treatments are complex.

Autoimmune Disease Research Autoimmune Disease Research

Autoimmune disease covers a wide spectrum of unmet medical needs. For example, in Lupus, physicians use a wide variety of medicines to treat the underlying disease, but the remaining unmet medical need is high. In Rheumatoid Arthritis, there are many treatment choices available to patients and, therefore, optimal treatment is individualized.

Chronic Obstructive Pulmonary Disease (COPD) Research Chronic Obstructive Pulmonary Disease (COPD) Research

Respiratory studies—particularly those for COPD—pose extraordinary logistical and clinical challenges for sponsors. inVentiv Health, having extensive experience in conducting COPD trials, has developed unique ways to overcome these challenges. We combine novel recruitment and retention strategies with innovations in study design to reduce risks and ensure that COPD trials complete on time and produce high quality data.

NDA Approval And Post Approval Services NDA Approval And Post Approval Services

From 2006 through 2015, Patheon helped clients earn 92 NDA approvals. That’s  twice as many as any other CMO. Success brings more success at this stage. That’s because depth of experience, reliability of quality and refinement of processes are all important in the final push for regulatory approval and making the transition to commercial manufacturing.

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.

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