How Not to Be an ATM for Your CRO with Outsourcing Checks and Balances

As a clinical trial sponsor, the overall value and expertise that can be gained in outsourcing services for clinical studies is clear. However, many partnerships don’t last long because they fail to deliver study milestones and quality work. When a CRO’s weaknesses overshadow their strengths, the partnership may be entirely terminated, rather than just replacing the service(s) that failed to deliver.

Small to midsize companies usually have limited finances and a shorter timeline to run a clinical program vs. Big Pharma. Any delay resulting from a partner’s failure to deliver on time has a greater impact on smaller Sponsors. Small to midsize companies trying to get innovative therapies to the clinic with just the right amount of money, should consider starting with functional CROs that have proven experience to get through all phases of clinical trials. These CROs can be as impressive and deliver overall savings from both a financial and timeline perspective.

Using a large or full service CRO does not mean less work or fewer functional team members, CRO’s study teams are usually located all over the world depending on their responsibility or the third party the CRO outsourced. How is this any different than using several specialized CROs to support study services (i.e. Data Management, Biostats, and Central Labs)? The same communication and protocol training is required for both options. However, with the functional CRO route, the sponsor will own the contract with the CROs and will have full transparency into the costs, milestones achieved, study delays and first-hand knowledge of the study impact regarding any protocol changes or database migrations. Outsourcing it all and leaving the contracting to CROs can sometimes leave a sponsor with big financial surprises and missed timelines that are out of the sponsor’s ability to manage and control.

In a functional model, a sponsor needs to make certain to emphasize quality and timelines when communicating with the CRO. They need to both agree on the responsibilities, deliverables and timelines prior to work execution. For Sponsors demanding urgency on the part of your CRO, they must be sure to meet the agreed upon timelines especially when the CRO is waiting for something before they can move forward to the next step.

Speakers

Erin O'Boyle, Senior Director Clinical Operations at Rezolute, Inc.

Erin O’Boyle has nearly 20 years of operational and management experience in conducting all phases of clinical trials from start to end. Prior to Rezolute, O’Boyle held clinical contracts and outsourcing roles at Fibrogen and clinical development positions at Heron Therpeutics. She brings a proven track record of implementing strong processes at the start of studies to save significant time, reduce timelines, eliminate duplication and  improve consistency across programs and trials.

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Stephen Boccardo, SVP Business Development, and Commercial Strategy, Quartesian

As SVP business development and commercial strategy, Stephen Boccardo handles all aspects of customer business development. He combines more than 30 years of life science industry experience and dedicated technology expertise with a record of success on the clinical data management and systems side as well as growing startup organizations through sales and marketing leadership. Boccardo joined Quartesian from Clinical Ink, where he served as Chief Commercial Officer. In this role, he was responsible for all Clinical Ink global sales and marketing activities to drive market adoption of the company’s industry-leading eSource products and solutions.

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