CRO or ARO: How to Hire and Manage One

Why Should You Attend:

A critical component in successful Clinical Research Trials is ensuring that you choose the right CRO/AOR based on the phase of the trial, the therapeutic area and the countries that the trials will be conducted. It is then important that the scope of the work be clearly defined to ensure that budget and timelines are respected and that the data collected will stand up to regulatory scrutiny. This protects both the CRO/ARO and the sponsor company. It also makes the job of the Project Managers on both sides easier.

This presentation will show how you can manage the CRO/ARO in this environment of multi-center, multi-country trials. We will discuss how you can ensure that you comply with regulations in the various countries from shipping drug to ensuring that the inclusion criteria are well understood in all countries and that the appropriate patients are enrolled. Diagnostic criteria are not always interpreted in the same manner. This is particularly true in some therapeutic areas such as CNS. We will also review the current trend towards enrolling pediatric patients as well as elderly and more vulnerable populations, and the challenges that go with it, in the various environments that studies are conducted.

Learning Objectives:

At the end of this session the participants will:

• Understand how to choose either a CRO/or ARO.
• How to write a scope of work that ensures effective study management for both the CRO/ARO and reduces the need for out of scope “budget busters”, and ensures the CRO/ARO will get repeat business!.
• Ho to ensure study is managed to timeline and budget.
• How to manage patient recruitment challenges.
• How to ensure that the data will stand up to regulatory inspection.
• How to Close out the study.

Areas Covered in the Seminar:

• How to choose and ARO or CRO?
• Writing a Scope of Work.
  • How to resource the trial for maximum efficacy.
  • Samples provided.
• Creating a budget that matches the scope of work.
  • How to prevent out of scope.
• Managing a CRO at the various phases of the trial.
  • Study Start Up.
  • Study Ongoing including Patient Recruitment strategies and plans.
  • Study Close Out.
  • Writing the Study Report Phase.
• How to work with other CROs/AROs to ensure continuity.
• Success!!!.

Who Will Benefit:

This webinar will provide valuable assistance to

• Study Project Managers at either CRO/AROs
• Project Managers at Pharmaceutical companies
• Business Development Managers
• Lead  CRAs
• Assistant Directors of Clinical Operations
• All interested parties

Instructor Profile:

Ethel Kagan R.N., B.A.

• Many years of experience in both the CRO/ARO and Pharmaceutical environment in a variety of roles and therapeutic areas
• Expertise includes managing AROs/CROs on behalf of pharmaceutical companies.
• Provide strong managerial and project management skills in a variety of therapeutic areas with most recent experience in Infectious Diseases, Hepatology, Gastrointestinal and Pulmonary Diseases.
• Provide therapeutic and clinical operations leadership to the functional groups, faculty and operations personnel.
• Oversee management of projects within the group.
• Assist with specific projects related to process improvement, patient recruitment, strategic planning and implementation of programs within the ID/GI group and Clinical Operations.
• Strong education and training background.
• Oversee the management of the projects with reference to achieving program and study objectives within budget and timelines.
• Provide guidance and oversight during due diligence audits by sponsors.

Topic Background:

CROs and AROs are increasingly being utilized to conduct Clinical Research Trials that are pivotal to providing the data to the FDA that will be used to decide if the drug and/or device is safe and effective and approved for human use.

Clinical Research Trials are expensive and time consuming and have to be conducted so that they are adequate and well controlled. When Pharmaceutical companies delegate the management of clinical trials to either CROs or AROs they still retain the legal obligation to ensure that they trials are safe and well conducted. There are certain steps that have to be followed to ensure that when you are the pharmaceutical company Project Manager or Director in charge of the trial that the studies are well conducted and will have data that will support the NDA.

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