| Pain: Chronic, Non-Malignant Pain
In a pain study for chronic, non-malignant pain, INC Research was tasked with enrolling 100 patients at 25 sites in 12 weeks. The customer did not anticipate IRB issues with Schedule 2 narcotics that caused a significant start-up delay. The actual enrollment timeline became 5.5 weeks. Only five Pre Study Site Visits were required for 25 sites due to INC Research's previous experience with the sites, and 17 initiation site visits were conducted in only nine days. INC Research exceeded enrollment by 23% in one-half the original timeline.
Pain: Chronic Painful Diabetic Neuropathy
A Phase III study in chronic pain by an international European-based pharmaceutical company involved 35 sites in six countries across Europe. The study medication was an opioid, which required our team to observe strict country specific regulations on import, export and storage of a controlled substance. The goal was to enroll 246 patients in four months. Study enrollment was challenging as the inclusion criteria required patients with moderate to severe pain, who were opioid naïve which is not common for patients with chronic DPN pain. Despite challenges in start-up which delayed FPI by 3 weeks, the original goal to enroll 246 patients was reached two weeks ahead of schedule.
Neurology: Stroke
In a recent North American stroke trial, INC Research was brought in to rescue the study. After passing leadership of the study over to an INC Research Project Manager with extensive stroke trial experience, strategic addition of 50% more sites took place immediately. Several added sites were key thought leaders in stroke with whom INC Research had developed a long-standing relationship. The customer adopted recommended protocol changes. Previous enrollment at 30 sites had languished at 20 patients in total over a 12-month period. With the addition of key sites and protocol changes recommended by INC Research, the enrollment rate was increased from 0.06 patients/site/month to 0.54 patients/site/month; 147 patients were enrolled in the study in only six months.
Psychiatry: Panic Attacks
In a European study for panic attacks, INC Research was in a competitive enrollment scenario with another CRO. Both CROs were tasked with an equal number of sites, with INC Research responsible for sites in Central and Eastern Europe. INC Research enrolled 70% of the patients to the competitors 30%, three weeks ahead of schedule. back to top |
Case Studies
Pain: Chronic, Non-Malignant Pain
Pain: Chronic Painful Diabetic Neuropathy
Neurology: Stroke
Psychiatry: Panic Attacks
Psychiatry: Major Depressive Disorder
Leadership
Michael Gibertini, PhD
Executive Vice President, CNS
Thomas Schlagheck, PhD
Vice President, Clinical Development, Global Analgesia
Thomas Zoda, PhD
Senior Vice President, Clinical Development, Neurology and Psychiatry
Biljana Andjelkovic, MD
Vice President, Clinical Operations, Global Analgesia
Warren Prosser, MBA
Vice President, Clinical Operations Global Analgesia
Andrew Silverman, PhD
Vice President, Neurology
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