Application Notes & Case Studies

  1. Achieve Continuous Supply Of Drug Treatment For Study Requirements

    A small sized pharmaceutical company was approaching the final phases of a large phase III global multiple treatment arm oncology study that involved comparator drug. The study criteria required the client to provide study medication to patients active at the conclusion of the study until the drug would be commercially available, when it could then be prescribed to patients continuing treatment.

  2. Versatility Of Softgel Technology: The Encapsulation Of A Volatile Compound

    A commercial stage medical technology company has developed SMART Softgels featuring a special shell to release quickly while still preventing evaporative loss during and after manufacturing. 

  3. Modernizing Clinical Trial Management

    Accelovance is a global company that oversees hundreds of clinical trial activities. Manual data entry was taking up hours of employees' time 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 integrated Respiratory, eCOA, Cardiac Safety and Centralized Data Surveillance solutions enabled the sponsor to prove efficacy and safety during the program, helping to 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 time-intensive manual data entry process. In this case study, learn how the company implemented 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, and the replacement of paper-based reports which led to reduced inefficiency and better communication among stakeholders.

  7. Optimizing Small Batch Size To Solve Formulation Challenges

    If current manufacturing practices are followed to handle small batches of API on industrial size machines, it results in handling difficulties and lower product yield.

  8. 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.

  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.