Reduce or Eliminate Changes of Scope: The Clinical Trial Budget Secret

Presenters: Brenda Reese, RN, BSN, CCRA and Arthur Czech
Original Air Date: October 19, 2011
Expiration Date: October 19, 2012
Contact Hours: Earn 1.5 ACRP or CBRN contact hours (only the purchaser is eligible)
Level: Intermediate
Cost: $119 Regular Rate; $79 Member Rate

Try Before You Buy

Who Will Benefit from Attending:

Project Directors and Project Managers at commercial sponsors who plan and develop RFPs for the CRO sector, as well as CRO Outsourcing Managers.

Course Description:

Pharmaceutical, biotech and medical device companies want to conduct faster, safer, less expensive clinical studies. But as the industry continues to innovate and adopt new technologies, one of the most expensive, time-intensive and potentially frustrating components of clinical study management remains unchanged: the change of scope. It’s the issue nobody likes to discuss.

Changes of scope affect both sponsors and CROs because they change the process. The CRO with an unrealistic budget wants to deliver the study properly, but is tied to the terms of the contract. The sponsor wonders if it’s worth the time, money and piles of paperwork required for even a small change.

This Webinar will offer actionable advice sponsors can take to create an RFP that decreases changes of scope:

1. Get the most thorough proposal. The amount of time and care invested in compiling an RFP is directly related to the number of changes sponsors will experience.
2. Ask the CRO to assign someone with clinical training and expertise to review and respond to the RFP, rather than a business development person. It’s a sponsor’s best chance for a comprehensive proposal because clinical professionals take into consideration all the contingencies that might come up during a study.
3. Do not assume that the lowest bid is the least expensive bid, or that the highest bid is the most comprehensive and will not have changes in scope. Sponsors get something different from every CRO. Budget should not be the deciding factor. But whatever bid a sponsor chooses, get the guarantees in writing.

A thorough RFP process with clear expectations from the sponsor and CRO reduces or even eliminate changes of scope and lets both parties focus on the end result: delivering quality data.

Learning Objectives:

Upon completion of this webinar, attendees should be able to:

1. Write clinical trial management RFPs
2. Identify each potential element that might affect the clinical trial - protocol, enrollment, timelines - and how to build in flexibility
3. Create ongoing communications strategies that bridge the potential gaps between sponsors, sites and the CRO

Presenters
Brenda Reese is VP of Business Operations at CRO DSP Clinical Research. She is committed to driving improvement and innovation in outsourced clinical trial management. With 16 years of clinical and corporate experience, she can anticipate and address the scientific and economic challenges required to obtain quality clinical research data. She has a wide depth of experience working at CROs and pharmaceutical companies. She is expert in all phases of clinical study management, with experience in a wide range of therapeutic areas. She has authored articles for publications including The Monitor. She is invited frequently to speak at industry events.

Arthur Czech, Clinical Research Manager, Ferring Pharmaceuticals, has a solid background in areas including clinical trial coordination, project management, budget preparation and guideline and legislation compliance. At Ferring, Mr. Czech is responsible for the overall coordination and leadership of a multifunctional trial team to ensure that key trial objectives are delivered according to agreed timelines and budgets.

Disclosure Statements
Brenda Reese states that she has no actual or potential financial conflict of interest in relation to this program.

Arthur Czech states that he has no actual or potential financial conflict of interest in relation to this program.

Program Numbers

Continuing Nursing Education
The California Board of Registered Nursing approves the Association of Clinical Research Professionals (ACRP) as a provider of continuing nursing education. ACRP’s webinar program provides 1.5 contact hours of continuing nursing education credit (Program Number 11147-2011-REP-320).

Association of Clinical Research Professionals
The Association of Clinical Research Professionals (ACRP) provides 1.5 continuing education credits for the completion of this educational activity with the completion of the online evaluation form.  These credits can be used to meet the certification maintenance requirement (Program Number ACRP-2011-REP-320).

Continuing education credits/contact hours are awarded with the completion of an online evaluation form, which must be completed prior to the product’s expiration date. Upon submission of the evaluation form, a link to the printable certificate will be made available on the attendee’s My Tests, Evaluations & Certificates page.