ComplianceOnline

How to Select a CRO; Best Practices

Instructor: Madhavi Diwanji
Product ID: 702425
  • Duration: 60 Min

recorded version

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Training CD

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Read Frequently Asked Questions

This webinar will outline the best ways to identify your trial needs to select a CRO, the right people to talk to, contract negotiations, ownership and accountability and challenges in the Sponsor-CRO relationship.

Course "How to Select a CRO; Best Practices" has been pre-approved by RAPS as eligible for up to 1 RAC credits towards a participant's RAC recertification upon full completion.

Why Should You Attend:

The success of a clinical trial will often depend on the sites’ abilities to conduct clinical trials in a timely manner. Because of the costs involved, sponsors need to select sites they know can recruit the right patients, follow the study protocol, respect deadlines, report clinical results adequately and retain trial participants. Selecting a CRO that is aligned with the sponsor’s goals is crucial factor in completing a successful trial.

This session will outline the best ways to identify your trial needs to select a CRO, the right people to talk to, contract negotiations, ownership and accountability and challenges in the Sponsor-CRO relationship. Someone who is unfamiliar with this process may end up spending hours of time over several days to weeks to get to the bottom-line. Learn how to complete this process very quickly and efficiently, translating to cost and resource savings for you.

Furthermore, this Webinar will be focused on the seven key traits that are needed by CRAs at CROs, in addition to the skills already identified to ensure success of the project for the sponsor as well as profit and repeat business for the CRO. In today’s competitive market, CRAs who can master these “key, above and beyond” traits will become “great” CRO CRAs. They become a valued asset within the CRO and within the clinical research field at-large.

Learning Objectives:

You will learn the best ways to identify your trial needs to select a CRO, the right people to talk to , contract negotiations, ownership and accountability and challenges in the Sponsor CRO relationship.

Areas Covered in the Seminar:

  • Identify your trial needs- match a CRO.
  • How to talk to the CRO and negotiate a contract.
  • Sponsor and CRO Relationship.
  • Ownership and accountability.
  • Utilizing the CROs experiences.
  • Challenges.

Who Will Benefit:

This webinar will provide valuable assistance to:

  • Sponsor personnel
  • Trial site personnel
  • Clinical Research Associates and other CRO personnel
  • Clinical Trial Investigators
  • Administrative managers in charge of Clinical Research

Instructor Profile:

Madhavi Diwanji, MBA, CCRC is the President of MD Clinical Monitor. She has tremendous experience in the healthcare industry in various roles for the past 20 years. She is well rounded in all aspects of clinical trial as she has been instrumental in healthcare research with a primary focus on cardiology and oncology. She has experience with monitoring clinical trials, conducting clinical trials, investigator initiated trials, maintaining multiple Trial Master Files, starting a research program in a hospital, health services research, regulatory /compliance submission and management, grant submission, business development and fundraising. She has successfully worked with different CROs, sponsors and IRBs. She has served on a study coordinator advisory committee of a global Congestive Heart failure clinical trial. She currently consults with helping clinical research departments in need of services like starting up, regulatory, closing down and increasing productivity.

Topic Background:

There is a wealth of information on the internet about CROs. Narrowing down the choices and finding the best fit for your needs may be something that can be managed by you.

After the initial internet search and asking colleagues, the next step will be to contact the vendors and begin the process of requesting more in depth information about particular study types and designs. Connecting with the right individuals to gather all of this critical information is not always as streamlined as one might expect. It is not uncommon for there to be a bit of a gap between business development and the science. Knowing who to speak to and how to cut through to the chase can make a tremendous difference.

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