Application Notes & Case Studies

  1. eTMF: Intelligent Submissions of Regulatory Filings

    A leading global contract research organization (CRO) was manually uploading site documents and associated metadata into their eTMF. Due to the complexity of (SSU) and variability of regulatory requirements for study countries and therapeutic areas, determining when all the documents needed for filing existed in the eTMF without multiple QC checks was a time consuming and burdensome activity. As the organization scaled with additional study volume, the efficiency and quality of the data going into the eTMF was causing audit risk and increasing FTE costs.

  2. Raymond James Financial Ditched Their Spreadsheets To Save Significant Time And Effort

    During various deals, the M&A team in the Raymond James Nashville offi ce relied on cumbersome manual processes for due diligence. For instance, to handle the question and answer process, the deal team used traditional met hods, conducting diligence via email and with Microsoft Excel® spreadsheets. Buy ers would create individual spreadsheets with different tabs for each category of questions, and submit them to Raymond James’s deal team. The deal team members then manually tracked the status and response of each question to en sure they sent the correct answers to the right bidder.

  3. Modernizing Clinical Trial Management

    Accelovance is a global that oversees hundreds of clinical trial activities. Manual data entry was taking up hours of employees’ days as well as adding unnecessary complexity and risk to the clinical trial process. In this case study, learn how the move to automation saved 90 operational hours per month, enabled staff to focus on other strategic endeavors, and provided actionable data that led to winning new business for the company.

  4. Global Pharmaceutical Company Drives Data Acceptability Over 95%

    What do you do when there are large discrepancies in your data? Learn how one leading global pharmaceutical company overcame this challenge. You’ll gain insight into how a new study design that leveraged ERT Respiratory solutions and Centralized Data Surveillance improved statistical outcomes and reduced site data quality issues, generated higher-quality data for regulatory submission, drove data acceptability to 95%+, and achieved database lock on schedule.

  5. Global Pharmaceutical Company Proves Efficacy Of Bronchodilator For COPD Patients

    A leading global pharmaceutical sponsor began a program of clinical trials to discover if a new bronchodilator could demonstrate superior and sustained lung function for patients with COPD. Learn how ERT provided integrated Respiratory, eCOA, Cardiac Safety and Centralized Data Surveillance solutions for this clinical research and how our integration supported the sponsor in proving efficacy and safety during the program which helped the company secure new drug approval from U.S. and European regulatory bodies.

  6. Automating Clinical Trial Management

    Premier Research, a leading clinical development service provider, struggled with their current time-intensive manual data entry process. In this case study, learn how the company implement a technology-based solution that was flexible enough to adapt to all their trial needs, including the improvement of employee productivity and trial data accuracy, the replacement of paper-based reports and reduced inefficiency, and better communication among stakeholders.

  7. 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.

  8. Modular Bioprocess Platform Gives CMO Maximum Flexibility

    Pharmaceutical companies are increasingly outsourcing product production to contract manufacturing organizations (CMOs). Doing so enables them to focus more of their resources on developing innovative new products and less on non-core, commodity activities, such as manufacturing. While this has been a boon for CMOs, it also creates new challenges as both their client base and related production demands rapidly diversify. Just staying on top of it all can be a big job.

  9. 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.

  10. A Competitive Race: Accelerating The Development Timeline With A Multi-Trial IRT Programme

    Time is always of the essence in clinical trials. But when competitors have the lead in bringing an alternative therapy to market, “the need for speed” takes on a whole new focus. This was the case with one top tier global pharmaceutical company that was just beginning its development program for several infectious disease indications.