06.10.15
INC Research Holdings, Inc., a global Phase I to IV contract research organization ( CRO ), has launched the industry’s first Site Advocacy Group (SAG) devoted to the scientific and operational aspects of clinical research. The SAG initially will focus on central nervous system (CNS) protocols—recognized as among the more complex therapeutic areas in clinical research—targeting psychiatry studies including, but not limited to, those in schizophrenia, attention-deficit/hyperactivity disorder (ADHD), depression and bipolar disorder.
“Through this forum, INC Research will collaborate with clinical research sites that have direct experience in psychiatry studies to gain their insights into the most common challenges and operational efficiencies that can be implemented for future studies,” said Clare Grace, vice president, site and patient access, INC Research Holdings.
A recent study by the Tufts Center for the Study of Drug Development found that drugs to treat CNS diseases, such as epilepsy, Alzheimer’s, autism, schizophrenia and depression, take 35% longer to develop than other drugs. Progress can be difficult to quantify with these diseases, making it even more critical for investigators and site staff to follow protocols consistently.
“Creating this SAG underscores INC Research’s commitment to better leveraging the expertise of clinical research sites worldwide in developing treatments for important health conditions,” said Michael Gibertini, president, clinical development. “Engaging with sites early on and in a meaningful way is critical to enhancing protocol design and study conduct. Our focus is on driving improved collaborations and innovative approaches to connecting more effectively with sites across all therapeutic areas as we work together to deliver on our ultimate goal of bringing new medicines to market for patients in need.”
Members of INC Research’s scientific and operational SAG specialize in psychiatry, with at least 10 years’ experience in schizophrenia, ADHD, depression and/or bipolar disorder, and have five years’ experience as a principal investigator . The group will be involved on an ongoing basis in reviewing protocols and providing feedback and solutions to enhance the conduct of psychiatry studies. The launch of INC’s SAG included a recent face-to-face meeting at the company’s Austin, Texas, location, which serves as a primary hub for its CNS clinical trials work.
“Through this forum, INC Research will collaborate with clinical research sites that have direct experience in psychiatry studies to gain their insights into the most common challenges and operational efficiencies that can be implemented for future studies,” said Clare Grace, vice president, site and patient access, INC Research Holdings.
A recent study by the Tufts Center for the Study of Drug Development found that drugs to treat CNS diseases, such as epilepsy, Alzheimer’s, autism, schizophrenia and depression, take 35% longer to develop than other drugs. Progress can be difficult to quantify with these diseases, making it even more critical for investigators and site staff to follow protocols consistently.
“Creating this SAG underscores INC Research’s commitment to better leveraging the expertise of clinical research sites worldwide in developing treatments for important health conditions,” said Michael Gibertini, president, clinical development. “Engaging with sites early on and in a meaningful way is critical to enhancing protocol design and study conduct. Our focus is on driving improved collaborations and innovative approaches to connecting more effectively with sites across all therapeutic areas as we work together to deliver on our ultimate goal of bringing new medicines to market for patients in need.”
Members of INC Research’s scientific and operational SAG specialize in psychiatry, with at least 10 years’ experience in schizophrenia, ADHD, depression and/or bipolar disorder, and have five years’ experience as a principal investigator . The group will be involved on an ongoing basis in reviewing protocols and providing feedback and solutions to enhance the conduct of psychiatry studies. The launch of INC’s SAG included a recent face-to-face meeting at the company’s Austin, Texas, location, which serves as a primary hub for its CNS clinical trials work.
