Application Notes & Case Studies

1. Scientific Functional Outsourcing Solves Sample Management Challenges In Clinical Studies 6/5/2020

   A major pharmaceutical company faced significant challenges managing the life cycle of its outsourced clinical and preclinical studies. The client’s internal analysts were developing assays and transferring them to global laboratories while also juggling the management of vendors and overseeing assay performance. However, without centralized, dedicated oversight, clinical timelines and quality were being challenged.

2. Protected Ambient Sample Shipping 6/5/2020

   A leading pharmaceutical research company needed help supporting a two-year clinical study of progressive multiple sclerosis. In order to accommodate multiple sampling time-points, the shipping kit needed to hold up to 17 test tubes in isolation, instead of the standard six or seven, and needed to maintain the test tubes within a very limited target temperature range despite exposure to extreme heat or cold for extended periods of time.

3. Unified IRT And Clinical Supply Aligns Processes To Meet Timeline 6/3/2020

   Unified IRT and clinical supply aligns processes to meet aggressive drug delivery timeline. Unifying the physical and digital aspects of clinical supply chain management with a single vendor has been proven to significantly reduce errors, demand less time and resource from sponsors, deliver process automation to drive efficiency, and offer a holistic view of data that facilitates smart decision making and continuous improvement. Download Almac’s case study to find out how one sponsor was able to meet ambitious study milestones, thanks to the Almac ONE service.

4. Delivering The Global Expertise Required To Coordinate A Pediatric Gene Therapy Trial 5/4/2020

   A European biotech company was conducting a pediatric trial involving a rare, incurable genetic disorder. In addition to new regulatory considerations, this trial also called for an extremely challenging intracerebral administration. To succeed, they needed a partner that could develop a clear, compliant strategy for obtaining informed consent and implementing an innovative data management plan to track patients between surgical and clinical sites.

5. How Ramping Up Communications Helped Overcome A Next-To-Impossible Recruitment Challenge 4/21/2020

   We knew going in that it could be the perfect recruiting nightmare with extremely complex inclusion/exclusion criteria. By letting sites set their own goals and commit to them along with assigning project coordinators that stayed close to those sites the study is off to a good start.

6. Clinical Ink And CRO Partner To Create A Disease-Specific Solution To Facilitate Lupus Clinical Trials 4/20/2020

   For sponsors and CROs, clinical trials for systemic lupus erythematosus (SLE or, more commonly, lupus) present a specific set of challenges that can impact the recruitment of investigators and patients and inhibit the ability to collect accurate data. This white paper discusses the challenges of diagnosing lupus, the unique difficulties lupus clinical trials face, and how the innovative eLAS platform helps meet these challenges.

7. Infectious Disease Teams 4/2/2020

   A not-for-profit Sponsor requested assistance with monitoring in an Ebola hot spot at trial naïve sites with little experience. Ultimately, the study required rapidly deploying solutions across diverse geographies. Read how the quick response and the geographic alignment of the team enabled the study to be completed.

8. Comparative Analysis For Non-IND Sites 4/1/2020

   A cancer research organization that facilitates the conduct of multi-national clinical trials was deep in the planning and
   coordination of a Phase III drug trial. The sponsor wanted to expand the trial to include German sites and had established important in-country partnerships for this purpose. The trial was being conducted under an IND, and everything was going according to plan until German regulatory authorities changed the rules. Read how Advarra Consulting provided in-depth analysis of German, European, and US regulations, allowing the cancer research study to move forward.

    

9. From KOLs To Patient Advocates, UsingEvery Tool To Fight A Rare Disease 3/11/2020

   With a recruiting target of 18 patients for a condition that afflicts just one in 31,000 people this CRO had to make full use of what few resources were avaiable. By working with KOLs and a patient advocacy group they located their 18 patients ahead of schedule and completed the 26-week trial early.

10. Vertex Data Management Team Cuts EDC System Build Times By Half With Veeva Vault CDMS 3/6/2020

    Read how Vertex Pharmaceuticals, Inc. reduced EDC database build times from 13-14 weeks for early phase studies to under 7.5 weeks today.