A Systematic Approach to Study Start-Up: Improving Site Activation

Course Description

The success of a trial relies on the strong bond between trial operations and project management throughout the trial life cycle. It is important to develop a specific knowledge of the strengths, weaknesses, and pitfalls of assumed risks at inception in order to devise mitigation strategies throughout the implementation phase. Systematic assessment of risk factors and key performance indicators at the start-up phase can allow for more efficient execution of a clinical trial and ensure better accrual rates. Best practices to expedite the start-up phase will also be discussed.

Learning Objectives

• Develop a sound business strategy for a more efficient study start-up
• Identify key performance indicators and risk factors contributing to start-up delays
• Perform cause-effect analysis of factors attributing to delays of start-up phase
• Implement mitigation strategies to avoid delays and allow for a successful trial launch

Who Should Attend

• Directors of Clinical Operations
• New Clinical or other Project Team Leaders who will be managing projects
• Clinical, Regulatory, Research and Development (R&D) Staff
• Physician Investigators
• Clinical Research Coordinators and Clinical Research Associates, Data Managers or others working in biomedical product development
• Regulatory Affairs
• Quality Control Professionals, Quality Assurance Specialists

Instructor

Marina Malikova, Ph.D., MSci, M.A., C.C.R.A., RAC

Click here for complete trainer biographies

Registration Fees

$735

Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com 

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-24-039-L99-P. Released: 11/24.

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.