Application Notes & Case Studies

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Improved Bioavailability Of Trio Medicines TML-2 In 12 Weeks

    Trio’s lead compound TML-2 is the acetyl prodrug of TML-1, a novel, well tolerated G-protein coupled receptor antagonist which shows clinical promise but has limited bioavailability owing to low solubility. Trio turned to Catalent for help.

  6. 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.

  7. 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.

  8. 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.

  9. Supplying Costly Investigational Product: Pre-Randomisation Approach Reduces Drug Wastage

    Certainly, every sponsor wants to minimize wastage in clinical trial supplies, but the motivation to do so is extraordinary when the product under study is unusually expensive. A top-tier, international pharmaceutical company engaged Almac to ensure that it did not incur undue drug supply costs for a global study involving a very expensive investigational product. With some ingenuity and customisations to the IXRS® platform for managing patients, supplies, and trial data, Almac helped the client re-envision its study design and supply strategy.

  10. Smart Start-Up: Combining Streamlined Processes & Leading Edge Technology

    A leading global contract research organization was contracted to conduct a two phase global oncology trial on behalf of a mid-sized Pharma company. The study was comprised of both phase I (dose finding and dose confirmation) and phase II (dose expansion) components. The original goal was to activate 20-25 sites for the phase I component and an additional 55 sites to be on boarded for phase II. By the time the protocol was received, sites had been selected and the First Site Initiation Visit (FSIV) was targeted to occur in less than five months. The core regulatory pack was due for finalization within 11 days of receipt of the protocol.