mary syto oct socal 11oct2015 final
TRANSCRIPT
Mary Syto, Sr. Global Project Manager, Receptos
IS IT TIME TO CHANGE YOUR CRO?
Disclaimer
The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Receptos, Celgene, Tragara Pharmaceuticals, its directors, officers, employees, partners, investors, or any organization with which the presenter is employed or affiliated.
18+ years of pharmaceutical development Key experience
- Global CRO for 8+ years
- Strategic clinical development in virtual and emerging pharmaceutical companies
- All phases and across a broad range of therapeutic areas
Mary Syto
Who are you?
Is it Time to Change your CRO?
Red flags to look for that show your CRO is putting your trial at risk
What are the risks associated with changing CROs? Tips for selecting the rescue CRO and transitioning
effectively to a new CRO
Your Dream Team
Skilled expertise Increased productivity
and efficiency Access to world-class
connections and solutions
Common culture and commitment to quality
Something is wrong…
Watch for Red Flags!
Bait and switch Staff turnover Slow start-up and site
initiation Slow patient recruitment Enrollment of pts that do not
fit protocol criteria Delayed timelines and missed
deliverables
More Red Flags! ARGH!
Delays in data collection and cleaning
Questions from sites sent directly to sponsor (not CRO)
Delays in regular status reports Delays in development of study
start-up plans Unresponsive team Lack of coordination with team
and vendors Recent CRO acquisition or merger
red herring
NOUN1. a dried smoked herring, which is turned red by the smoke.2. something, especially a clue, that is or is intended to be misleading or distracting.
Identify red flags but distinguish them from red herrings
Common project risks
Staff turnover
Delays with Pt Recruitment
Delays in Study Start-up
Unclear expectations
Over budget
Issues with Vendors
Poor communication
Staff turnover
Is it Time to Change your CRO?
You recognize that your trial is off course. Did you (or someone else) make a mistake in the
CRO selection process in the first place? Should you change your CRO mid-study? Is change your only option? How much more work will this be? Will the next CRO be any better?
Other solutions
Take work in-house
Consultants
CRO hybrid
approach
Is the grass greener with a new CRO?
Selecting a Rescue CRO
CRO to address all your needs (and save your study!)
Better performance, quality, speed, efficiency
Reset button
Advantages
Selecting a Rescue CRO
Increased $$$ White space, lost time Need buy-in from Sr.
management? Blame for 1st CRO
selection More work for you Not might fix the issues
Risks
It’s complicated.
Regulatory submissions may be in process Any contractual obligations? Penalties? Vendor contracts may be held by incumbent CRO Costs too much $ to move database or platforms?
Incumbent CRO may need to be retained for data management and biostats
Do you move all services or some?
Tips for Selecting a Rescue CRO
Be honest and frank Share details about current
challenges Focus on expertise that is
lacking in the incumbent CRO
Be realistic
Details on past “rescue” experience
Transition strategy and hand-over process
Expedited projections and timelines
Their recommendation and back-up strategy
Things to Remember Info to Request
Transition effectively to a new CRO
Inform incumbent CRO Be honest and transparent
with plans Don’t burn your bridges Set timeline for the transfer
of obligations Schedule kick-off/hand-off
meeting and regular meetings (as needed)
Create checklists for the transfer of documents
Negotiate $ and timeline carefully so incumbent CRO can complete tasks
Minimize and manage process change for the sites
Inform vendors
Key Takeaways
Identify red flags but distinguish them from “red herrings”
Work hard to salvage the partnership with your current CRO
Critically evaluate if change is your only option
Examine all the advantages andrisks with the “rescue” CRO
Transition effectively by having a strategy and plan
