White Papers

1. The Role Of Long-Acting Injectable Antipsychotics In Schizophrenia 10/22/2020

   Use of long-acting injectable antipsychotics is often reserved for patients with chronic or treatment-refractory schizophrenia or repeated non-compliance issues. However, recent studies have consistently found a role for these treatments both soon after diagnosis and in the treatment of chronic disease. In this white paper, we will review the symptomatology and pathophysiology of schizophrenia and discuss the pros and cons of treatment with LAIs. We will also explore the challenges of conducting studies in schizophrenia and offer suggestions for maximizing the likelihood of success in clinical trials of these drugs.

2. Strategies For Collecting Quality Data In Psychiatric Clinical Trials 10/22/2020

   Sponsors of psychiatric clinical trials may face significant challenges in collecting robust, quality data to support the efficacy and safety of investigative compounds. Identifying and mitigating study design-, subject-, and site-related factors that may influence data quality as early as possible in program development can help to drive study success. In this white paper, we explore a range of factors that, if identified and mitigated early in the development process, can maximize the potential for conclusive study results in psychiatric clinical trials.

3. Implementing Study Amendments Without Downtime Or Data Migrations 10/19/2020

   Companies can save time and money by implementing amendments in near real-time with Veeva Vault EDC. The benefits are considerable: the desired changes go into effect faster, administration costs are minimal, and downtime for sites is eliminated. Learn how your trials can become more agile in this white paper.

4. The Ultimate Guide To Purchasing A Clinical Trial Study Participant Reimbursement System 10/16/2020

   This guide focuses on important areas to evaluate when vetting a platform for clinical research participant reimbursement. These crucial elements will help ensure the system you select improves the participant experience without increasing the burden on site staff.

5. Lessons Learned When Implementing A Risk Management Program 10/14/2020

   The design and implementation of risk management programs can be challenging. This white paper uncovers key lessons learned from our experience with over 120 RiskMAPs and REMS programs - which spans various therapeutic areas and targeted risks.

6. Developing Gene-Based Therapeutics 10/6/2020

   The regulatory, operational, and commercial forces that impact gene therapy development continue to evolve dramatically – not just in the US but throughout the world. This paper explores strategic considerations for regulatory, operational, and commercial success.

7. A Multi-Pronged And Customized Approach To Rare Disease Clinical Trial Patient Identification And Recruitment 10/5/2020

   Research and development investment in rare disease treatments continues to grow and challenges remain in the global identification and recruitment of eligible patients for specific indications with a low disease prevalence. Leveraging precision medicine, data-driven solutions and collaboration across the rare disease community are instrumental when developing a customized strategy for patient identification and recruitment.

8. HHS Officially Closes Non-Disclosure Loophole 10/5/2020

   The Federal Court in Seife determined that in issuing a “Final Rule” HSS misinterpreted, and thus misapplied, certain clinical trial reporting requirements found in FDAAA. This white paper assesses the impact of a recent federal court ruling on clinical trial disclosure compliance and health authorities’ announcements upholding it.

    

9. Making Data Central To Your CNS And Pain Trials 9/24/2020

   CNS and pain trials are demanding from a data capture standpoint: Complicated eligibility criteria, extensive monitoring requirements, comprehensive data collection, and substantial demands on patients all must be overcome. After consulting with key opinion leaders from CROs and pharma we learned the solution was a product with a well-thought-out functionality specific to the therapeutic area coupled with highly consultative, experience-based guidance that ensures clients receive a complete data collection solution that fulfills their exact needs.

10. Overcoming Common Challenges Of Clinical Data Review 9/21/2020

    Clinical data review is an intrinsic component of clinical development aimed at assuring patient safety, determining drug efficacy, and assessing data quality. It involves rigorous analysis of a broad variety of clinical trial data and often necessitates integration of data from multiple sources in order to extract actionable insights. Here, we look at some of the main challenges of clinical data review and discuss effective strategies to address these, before explaining how our solutions can be deployed to bring urgently needed therapeutics to patients faster.