Women’s Health Specialty CRO Presents Webinar, “Is a Specialty CRO Right for You?”
Webinar draws on experience from both sponsor and CRO perspectives
Durham, North Carolina. Health Decisions, Inc., the full-service clinical research organization of choice for forward-looking biopharma and medical device companies and a leader in women’s health and diagnostics studies, today announced that it will present a webinar on key issues in considering a development partnership with a specialty CRO. During the webinar, seasoned clinical development professionals will discuss sponsor-CRO relationships based on experience working for both types of organizations.
“Biopharma companies must consider many issues in evaluating a potential clinical development partnership with a CRO and certain issues take on particular importance when considering a partnership with a specialty CRO,” stated Health Decisions’ Chief Executive Officer Patrick Phillips, BSc (Hons), D.Phil. “As someone with extensive experience working for biopharma sponsors as well as general and specialty CROs, I wanted to offer this webinar to assist sponsors in deciding whether a partnership with a specialty CRO is right for them.”
Like Dr. Phillips, Health Decisions’ Head, Clinical Operations, Kevin Bickford understands sponsor-CRO relationships from both sides of the table. “My experience as a Senior Program Manager for a therapeutically-focused development program at a global biopharma company allows me to see the issues in CRO-sponsor relationships from the perspective of a therapeutically-focused unit within a larger biopharma company and a therapeutically-focused biopharma company,” stated Mr. Bickford. “The goal of this webinar is to give sponsors insight into key considerations in assessing the pros and cons of working with a therapeutically-focused CRO.”
During the webinar, Mr. Bickford will address topics such as assessing the benefits of a shared therapeutic focus in areas including access to an appropriate site network, the project team’s experience with the patient populations to be enrolled in future clinical trials and the specialty CRO’s understanding of key success factors in trials in a specific indication. “Clinical trials in specific therapeutic areas and indications present distinct challenges in several key areas, including site selection and patient recruitment,” said Mr. Bickford. “In considering a partnership with a specialty CRO, evaluating the potential benefits of a shared therapeutic focus is a key consideration.”
Clint Dart, MS, Health Decisions’ Senior Director, Biostatistics and Programming, will discuss the advantages of initiating a relationship with a specialty CRO with an early consulting engagement on regulatory strategy or protocol development. “While early engagement is not always possible,” said Mr. Dart, “there are substantial benefits in building a working relationship before jointly conducting a clinical trial.” Mr. Dart will also discuss considerations in optimizing an ongoing relationship between a sponsor and a specialty CRO.
Kristen Snipes, CCRA, CCRP, Associate Director of Clinical Operations at Health Decisions, will discuss another key issue in selecting a specialty CRO: assessing the cultural fit between organizations. “Sponsor RFPs and CRO proposals address many questions well but these types of formal documents are not the best tools for assessing a cultural fit that is so important to the success of a clinical development partnership,” said Ms. Snipes. “Based on my experience on both the sponsor and CRO side, the webinar will include tips and techniques for determining whether there is a cultural fit between two organizations that will make a development partnership more productive.”
“Is a Specialty CRO Right for You?” will take place Tuesday, June 12, 2018 at 1pm EDT (10am PDT). Complimentary registration for the 60-minute webinar is open for all interested in participating.
About Health Decisions
Health Decisions is a full-service CRO offering therapeutic, operational and regulatory excellence for clinical development of drugs, diagnostics, medical devices and combination drug/devices in all areas of women’s health. Based on therapeutic and operational experience and investigator relationships developed in studies conducted over the past 28 years, Health Decisions successfully addresses the challenges of developing diagnostics in all therapeutic areas and drugs and devices in areas including reproductive and sexual health, menopause, pain management, osteoporosis/osteoarthritis, reproductive psychiatry, gynecologic oncology and general gynecology indications. Health Decisions is headquartered in Durham, NC.
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+1 919.967.1111 ext. 520
lhammill @ healthdec.com