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FEATURED ARTICLES

  • Clinical News Roundup: CTTI Issues Recommendations For Pediatric Trials
    Clinical News Roundup: CTTI Issues Recommendations For Pediatric Trials

    Clinical news roundup for the week of February 12, 2017 featuring information on new CTTI recommendations, China’s trial application backlog, adaptive trial design adoption, growth in the mHealth market, and Merck’s Patient-Centered Cancer Care Access.

  • The Science Of M&A: Making The Most Of Your Financial Resources
    The Science Of M&A: Making The Most Of Your Financial Resources

    As CEO for France-based biotech Onxeo, CEO Judith Greciet is always looking for new opportunities to bring complementary products on board to expand her company’s pipeline. Onxeo currently has three compounds in clinical development, with one at the end of its Phase 3 trial. “External development is a key path in our strategy to grow the company,” says Greciet. “Whether you refer to this as an acquisition or inlicensing, we knew we would require additional, innovative assets to widen our pipeline and increase the value of the company.”

  • Paratek Successfully Tackles Patient Challenges in Phase 3 Trial
    Paratek Successfully Tackles Patient Challenges in Phase 3 Trial

    Paratek bills itself as a pharmaceutical company developing innovative medicines based on tetracycline chemistry. In this Q&A, Dr. Evan Loh, president and COO for Paratek, discusses some of the clinical challenges faced when enrolling patients for the ongoing Phase 3 studies. In addition, he notes how completing these studies will position the company for a new drug application as early as the first half of 2018.

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WHITE PAPERS AND CASE STUDIES

  • 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.

  • Clinical Trials Breathe Life Into Standard Operating Procedures (SOPs)
    Clinical Trials Breathe Life Into Standard Operating Procedures (SOPs)

    Standard Operating Procedures (SOPs) have long been fundamental to many industries, and the clinical trials sector is no exception. With the advent of the Good Clinical Practice Guideline in 1996 from the International Conference on Harmonisation (ICH-GCP), stakeholders have been motivated to develop SOPs, not only for regulatory compliance, but also as a routine business practice. SOPs are defined in the GCP Guideline as detailed, written instructions needed to achieve consistent performance for a specific function,1 with a goal of instilling quality into clinical trial operations. Yet, too often, after companies devote significant time and resources into creating SOPs, they may not be followed. They may be ignored or even avoided.

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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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