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INC Research propels Catalyst into psychiatric arena
RALEIGH, N.C.—INC Research recently announced the launch of its Psychiatry Catalyst Site Network, the latest component of its Catalyst program. The Psychiatry Catalyst Site Network joins the existing Oncology and Vaccine networks in the Catalyst suite, which was introduced in 2016 to strengthen collaborations with clinical research sites worldwide.
The Psychiatry Catalyst Site Network was developed in response to the rapid growth of psychiatric studies, and aims to enhance patient focus and optimize study delivery to drive improved predictability and increased efficiency for customers. INC began with 32 high-performing clinical research sites to participate in the initial launch of the network, with the goal of enhancing high-quality delivery for biopharmaceutical customers.
“Demonstrating our continued focus on strong site collaboration to improve study delivery, INC Research has expanded its Catalyst program into the central nervous system (CNS) and, specifically, psychiatry clinical research,” says Dr. Clare Grace, vice president of site and patient access for INC Research. “Our Catalyst initiative aligns with INC’s deep therapeutic focus and supports the delivery of high-quality, actionable data to advance new therapies. Our expansion of the program in response to the growing number of psychiatric studies—recognized as among the more complex therapeutic areas in clinical research—will leverage expert insights to further enhance clinical development and accelerate new therapies to market in this critical area.”
The Catalyst program offers benefits to sponsors, practicing sites and patients by providing a framework for the development of enhanced clinical trial methodologies and technologies, ultimately speeding the development of therapies to patients. The Catalyst sites benefit from increased volume of clinical trials and a dedicated relationship manager, supporting each site and facilitating improved alignment of protocols to site interests and expertise. The participating sites also have the chance to benefit from knowledge and perspectives of other sites in the network.
“Specifically, sponsors benefit from the Catalyst program because we’re able to deliver studies and high-quality actionable data more quickly and more predictably through high-performing clinical trial sites,” according to Tracey Gashi, executive director of site and patient access at INC Research.
INC’s Psychiatry Catalyst Network will reportedly play a significant role in the psychiatry studies the company conducts on behalf of its customers, particularly in the more challenging psychiatric indications.
“Many of the newer schizophrenia and depression studies require a greater commitment from investigators than in previous years, and INC’s Catalyst program provides a strong foundation by establishing clear and mutually agreeable expectations regarding the administrative aspects of running a clinical trial from the onset,” says Dr. Tom Zoda, executive vice president and general manager for CNS clinical development at INC Research. “By easing the administrative burden for sites, we are better positioning them to spend more time focusing on enrollment of suitable patients and engagement of their caregivers. Our goal through the Psychiatry Catalyst Site Network is to raise the caliber and quality of work in psychiatry clinical trials for the ultimate benefit of patients in need of these medications.”
The initial 32 sites were selected based on previous experience, which included the number of studies run in the psychiatry area, their previous delivery across multiple studies and the quality of data previously provided. Sites will work with each other and with INC Research to deliver studies more quickly and more predictably, with the aim of enabling the company to better deliver on the needs of its customers. Participation is by invitation only, with membership initially focused on the United States. Membership will be reviewed regularly to ensure the network is meeting customer needs.
“I am excited to be part of INC’s Psychiatry Catalyst Site Network, which builds on its Protocol Review Site Advocacy Group implemented in 2015 to engage sites earlier on in the scientific and operational aspects of CNS clinical trials to improve patient engagement and ultimately study delivery,” says Dr. David Walling, a principal investigator with Collaborative Neuroscience Network LLC.
Dr. Andrew Kim, principal investigator with Alexian Brothers Center for Psychiatric Research, added, “Improving communication and reducing redundancies among sponsors, CROs and sites enables us to overcome obstacles and barriers more efficiently and deliver potential breakthroughs to patients in a more timely manner. The Catalyst Psychiatry Site Network helps to create this collaboration, which I am proud to support.”
Over the past five years, INC Research has conducted more than 115 psychiatry studies across all phases of development, including complex studies that address conditions like schizophrenia, suicidality, depression and dementia. The company’s significant experience in overcoming enrollment challenges, meeting site needs, implementing protocol amendments and surpassing customer expectations are all key differentiators to its clinical research success, according to INC.
INC Research currently runs global Catalyst networks across a number of therapeutic areas and indications. Since launching in 2016, they have created networks for vaccines (United States), oncology (United States and the Asia-Pacific region), early phase (Australia) and now psychiatry (United States). The company expects to continue the expansion of the Catalyst program to include additional therapeutic areas, indications and regions. In addition to the Psychiatric group, the company also provides an online forum community, which is open to all sites, to support ongoing communication on the conduct of clinical trials, wider adoption of new methodologies and the sharing of best practices.
INC and inVentiv complete merger
RALEIGH, N.C. & BOSTON—On Aug. 1, INC Research Holdings Inc., a global Phase 1-4 contract research organization (CRO), and inVentiv Health Inc., a privately held global CRO and contract commercial organization (CCO), announced the successful completion of their previously announced merger.
The combination creates what they say is “the only fully integrated biopharmaceutical solutions organization,” including an end-to-end CRO and CCO. INC Research/inVentiv Health will continue to trade on the NASDAQ Global Select Market under the symbol INCR. The combined company will be known as INC Research/inVentiv Health on an interim basis until a relaunch under a new brand in 2018.
“The closing of this deal marks the beginning of an industry-changing new company, purpose-built to achieve the singular goal of accelerating biopharmaceutical performance,” said Alistair Macdonald, CEO of the combined company, which he maintains “will address new market realities through shared clinical and commercial expertise, data and insights to meet the needs of biopharmaceutical companies of all sizes. This strategic combination enhances our ability to facilitate approvals and product launches in multiple markets worldwide, and the value we offer to employees, customers and our shareholders.”
Michael Bell, executive chairman of the board of directors and president of the company’s Commercial Division, added: “With the industry’s most comprehensive clinical and commercial solutions continuum [we] are confident in the company’s ability to meet the needs of biopharmaceutical companies who are navigating an increasingly complex marketplace ... We are pleased with transition progress to date, look forward to supporting our talented management team and are committed to enabling our customers to speed the delivery of therapies to the patients who need them most.”