Health Decisions, the leading women’s health CRO, is offering a webinar on determining whether working with a specialty CRO is the best way to advance your clinical development program. Three speakers with extensive experience in CRO-sponsor relationships in clinical development programs and studies will discuss considerations in deciding whether to work with a specialty CRO, including:

  • The importance of finding a match between company cultures
  • The potential benefits of specialized expertise and early engagement
  • The advantages offered by a core therapeutic focus shared between organizations

Kristen Snipes, Associate Director of Clinical Operations at Health Decisions, will discuss the process for identifying a development partner with a company culture adaptable to your needs and preferences. This will include assessing the importance of a development partner’s organizational agility to achieving your development and business goals as well as the availability of staff committed to the success of your program.

Clint Dart, MS, Health Decisions’ Senior Director, Biostatistics and Programming, will discuss topics including the advantages of initiating an intra-company relationship on a consulting model for regulatory advice and protocol design or review before jointly conducting a clinical trial as well as optimizing working relationships during clinical trials.

Health Decisions Head, Clinical Operations, Kevin 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 relevant patient population and its understanding of key success factors in trials in your target indication.

Speakers

Kristen Snipes, Associate Director, Clinical Operations, Health Decisions

Kristen Snipes has more than 19 years of experience in clinical operations and project management. Her experience includes managing sponsor-CRO relationships and directing strategic and operational initiatives at the department and corporate level. She has proven ability to drive innovation, oversee cross-functional teams and high-complexity projects, and supervise high-performing staff in biotech, pharmaceutical, and clinical research organizations. Ms. Snipes is an analytical, results-oriented leader with extensive knowledge of regulations, project management principles and processes and their interaction with technology to drive productivity and provide excellent customer service. Ms. Snipes’ experience includes phase 1 – 4 studies in therapeutic areas including oncology, hematology, CNS, cardiology, respiratory, device and dental studies. Her oncology experience includes a phase 2 breast cancer study. Ms. Snipes’ articles have appeared in publications including Clinical Informatics News, Clinical Leader and Contract Pharma. She received a Bachelor of Arts in Chemistry from Colby College.

Message Presenter

Clint Dart, MS, Senior Director, Biostatistics and Programming, Health Decisions

Clint Dart has over 20 years’ experience as a biostatistician, including designing, preparing, and reviewing clinical study protocols, with focus on statistical analysis and sample size/power calculations. Mr. Dart’s extensive experience in women’s health studies includes serving as Principal Investigator for Health Decisions in its role as Statistical and Clinical Coordinating Center for the Contraceptive Clinical Trials Network of the National Institute of Child Health and Human Development, a unit of the National Institutes of Health. At Health Decisions, Mr. Dart directs the biometrics, data-management and medical writing groups. He has led the statistical efforts on 20 pivotal women’s health studies. Mr. Dart holds an MS in Statistics from the University of Georgia and a BS in Mathematics from the University of Cincinnati.

Message Presenter

Kevin Bickford, Head of Clinical Operations, Health Decisions

Kevin Bickford is a clinical operations executive with 20 years of clinical development experience spanning many therapeutic indications and virtually every phase of clinical research. Mr. Bickford provides executive oversight for a focused, specialized, and dedicated Health Decisions Operations team specializing in women’s health. His experience includes providing team leadership and executive oversight for both sponsor and CRO companies and managing operational groups ranging from large global teams on multi-protocol development programs to small teams executing studies of investigational products for rare disease and orphan indications. Mr. Bickford’s experience in women’s health studies includes directing programs for accelerated start-up in a variety of indications. His therapeutic experience includes not only studies of novel drugs, but also studies of diagnostics, other medical devices and Over-the-Counter (OTC) drug reformulations. Mr. Bickford focuses the Health Decisions operational team on service delivery, effective partnership among study team stakeholders and effective risk, quality and resource management. He is skilled at analyzing operational and performance metrics to guide sponsor and provider team members toward the best path for successful study conduct. Mr. Bickford has a BS in Biological Sciences from the University of Vermont and certification from Northeastern University as an Emergency Medical Technician.

Message Presenter

Who Should Attend?

Pharmaceutical, Biotech and Diagnostic companies, with emphasis on the following titles:

  • Chief Executive Officer
  • Director of Research and Development
  • Executive Vice President for Clinical Development
  • Director of Clinical Operations
  • Vice President, Clinical and Regulatory Affairs
  • Directory, Regulatory and Clinical Affairs
  • Vice President, Clinical Affairs
  • Director of Product Development

What You Will Learn

Speakers will discuss considerations in deciding whether to work with a specialty CRO, including:

  • The importance of finding a match between company cultures
  • The potential benefits of specialized expertise and early engagement
  • The advantages offered by a core therapeutic focus shared between organizations

Xtalks Partner

Health Decisions

Health Decisions (www.Healthdec.com) is a full-service women’s health specialty CRO dedicated to improving healthcare outcomes for all women globally. Health Decisions has 28 years of experience conducting studies of drugs, diagnostics, medical devices and combination drug/devices for reproductive-health indications. As the only full-service women’s health specialty CRO, Health Decisions provides efficient, high-quality services enabling developers of women’s health products to bring new products to market with maximum quality, speed and efficiency. Experience includes successfully executing studies and supporting regulatory submissions of a variety of women’s health products for the full spectrum of indications in women’s health, including major OB/GYN indications, infectious conditions, contraception and infertility as well as breast cancer and gynecologic oncology indications. Health Decisions has supported successful NDA, 505(b)(2), PMA and 510(k) submissions for many types of women’s health products. Health Decisions’ clients include biopharmaceutical and medical device companies, governmental agencies and non-profit organizations worldwide. Health Decisions is headquartered in Durham, NC.

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