If you’re a sponsor responsible for outsourcing your clinical trials or someone who is curious about what clinical trial outsourcing entails, you’re in for a treat.

Our guest today is Anca Copaescu, CEO at Strategikon Pharma.

Outsourcing a multi-million dollar clinical trial is not as simple as calling a CRO, signing a contract, and spending the money. 

Selecting and identifying the right partner for your clinical trial is a complicated endeavor that requires you to be organized with your time, money, and process. 

Furthermore, sponsors want the best deal when it comes to outsourcing. Nobody likes to spend more money than they ought to. 

In this episode, Anca shares with us how you can achieve your outsourcing and budget management goals in the most efficient and organized manner, best practices for outsourcing and due diligence for large and small biotech companies, questions to ask during vendor selection, and more. 

Anca and her team are helping biopharmaceutical companies plan and budget clinical trials, select and manage clinical trial suppliers, and contracts using software applications. 

Prior to her work at Strategikon, Anca served as the Sr. Director, Head of Clinical Outsourcing and Analytics at Biomarin Pharmaceuticals, Director of Corporate Development at Icon Clinical Research, Director, Strategic Planning at Pharmanet Development Group, among many other roles.

Please join me in welcoming Anca to the show.

Anca Copaescu on LinkedIn

Sponsor:

This podcast is brought to you by Slope. Slope provides an online eClinical Supply Chain Management (eCSCM) platform for sponsors and research sites collaborating on complex, sample-intensive, early-stage clinical trials. To learn more, visit slope.io

Resource List:

Strategikon Pharma

BioMarin Pharmaceuticals

ICON Clinical Research
Pharmanet Development Group

Contract/Clinical Research Organization (CRO)

RACI Structure

DIA TMF Reference Model 

Electronic Data Capture (EDC)
Clinical Trial Management System (CTMS)

“Silos”

“Sandbagging”

RACI

Alexander the Great

Napoleon Bonaparte

Fyodor Dostoevsky 

Excel

Books and Literature Mentioned: 

Measure What Matters – John Doerr (Amazon, Barnes & Noble)

The Idiot – Fyodor Dostoevsky (Amazon, Barnes & Noble)

Maurice’s Strategikon – Maurice (Amazon, Barnes & Noble)

Show Notes:

[2:48] Anca Joins and Introduces Herself

• Background in finance – spent majority of career at the crossline between business aspects of clinical operations and clinical trials
• Worked both for CROs and Sponsors
• CROs primarily pricing through Excel based tools
  • Introducing likelihood for errors and makes managing complex assumptions difficult
• Goal of Strategikon Pharma was to standardize outsourcing

[7:11] Defining Outsourcing

• Term often coined by business operations
• Involves all of the non execution aspects of running a clinical trial
• Pharma is very outsourcing heavy
  • $40-60 billion spent annually on outsourcing
• Outsourcing partners include Clinical/ Contract Research Organizations (CROs), Electronic Data Capture (EDC), (Clinical Trial Management System) CTMS, laboratory services, or patient recruitment services
• Outsourcing groups need to plan these activities and manage their contracted partners

[10:10] Challenges with Standardization

• Industry lacks motivation to standardize the practice of outsourcing
• DIA Reference Model for eTMF represents a successful standardization
• Standardization competes against the current status quo
  • By standardizing, we will all “speak the same language” and contracting can be made easier

[12:41] Recommendations to Overcome Outsourcing Challenges

• Standardization is like writing down a recipe. It makes the process of outsourcing more consistent
  • Need to provide the tools and documents that work within a standardized framework
• Round table discussions open the door for companies in the medical research space to get together and work towards standardization
• Changes are often at the definition and terminology level
• Resistance comes from many of us working in “silos” isolated from what other groups are doing
• Resistance also comes from fear that standardization will drive prices down
  • Bidding exposes the cost structure of service providers
• Challenges bringing about visibility and transparency between companies within the industry
• Large sponsors have datasets of historic bids that are not being leveraged adequately to standardize pricing structures for outsourcing

[23:31] Explaining Outsourcing Strategy

• Outsourcing bids for services happen at project outsets and then happen again for reach new project
  • Information collected from doing these bids is often not referenced or entered in a database to be leveraged for future bids
• Smaller Players don’t have the clinical trial experience to select vendors as well as larger companies
  • Know the science but may not know the industry
  • Would be helpful if these groups could leverage the knowledge of historic bids from other companies
• Large Players are sitting on a goldmine of contracting and bidding data that is not being utilized adequately 
• Lack of information creates challenges for startups when asking for investor funding

[29:23] Useful Tools

• Unfortunately there aren’t a ton of sophisticated tools for managing outsourcing
• Conferences and podcast are helpful but also won’t provide you with a “how to manual”
• There is a need for more education in this aspect of the industry
  • Helps people to ask the right questions
• Tools for Sponsors to data share would be tremendously helpful for the industry

[33:11] Common Mistakes in Clinical Trial Outsourcing

• Contracts need to be carefully monitored to make sure they are delivering against what was promised
• Financial management and forecasting is critical for predicting the future outsourcing needs and understanding your current spending
• Developing metrics and means of enforcing the contract with your outsourcing partner helps to ensure the work is successful 

[36:40] Sponsor Messsage: Slope Clinical (https://www.slopeclinical.com/)

[37:43] Common Misconceptions About Clinical Trial Outsourcing

• People need to value the data and the process
  • Does your outsourcing partner use a framework that promotes healthy dialogue or does it sandbag the conversation?
• Outsourcing isn’t just transactional
• Outsourcing doesn’t have to be complicated. It is worth spending the time to trying to simplify the complexity to have a more clear conversation with potential partners

[40:21] Frameworks for Outsourcing

• Frameworks exist for both outsourcing and vendor management
• Outsourcing: Develop a common understanding of activities required > use that defined list of activities to have a deeper dialogue > align on core assumptions about what your group and the vendor are responsible for doing
• Using a RACI structure to make sure you understand what people are responsible for doing
• Simplify your metrics to what is necessary for tracking the project

[44:46] Differences Between Small and Large Biotech Company Outsourcing

• Both can learn from each other in different ways
  • Small companies should strive to improve their structure and leverage the available expertise within their field
  • Large companies should seek to simplify what they can and not create unnecessary complexity

[44:47] Outsourcing Best Practices

• Consider aspects of running a research trial on a continuum
• Source competitively and strategically to find the best partners and best deals
• Leverage your past knowledge of outsourcing to inform your future outsourcing efforts
• Compare the Actual against the Plan

[50:01] Important Vendor Selection Questions

• Make sure you have some structured approach to qualifying your vendors
• Ask questions relating to their ability to execute and their experience in the work they are doing
• The process has unfortunately strayed away from Sponsors asking vendors critical questions

[57:04] Anca’s Closing Thoughts

• Find her on LinkedIn and reach out to ask questions
• Standardization is a path forward to sustainability
• There is tremendous wealth of knowledge out there we need to leverage better

[58:41] Sponsor Message: Slope Clinical (https://www.slopeclinical.com/)

Major Themes:

1. Outsourcing happens in almost all clinical trials in some capacity. Lack of standardization in the outsourcing process makes the contracting process both expensive and often time consuming
2. Many sponsors are sitting on a wealth of data from past outsourcing efforts that they are not leveraging to standardize outsourcing for future studies. Round tables and transparent collaboration between companies can help standardize outsourcing practices. 
3. Successful outsourcing involves both active relationship management and expectation setting so all partners are in agreement. It is important to develop agreed upon performance metrics to compare the output of the contracted work with what was in the plan.

Quotes:

1. “There is a perception that there is some secret sauce in the pricing. My opinion is that there is almost no secret sauce, because even the costing tools have circulated sinfully between different service providers, the secret sauce is in the quality of the execution.” 
2. “One of the important things is to look at all of the aspects of running the business side of trials in a continuum.” 
3. “Encourage everyone to have courage in trying out change and not be afraid of the change but embracing it. I think the industry needs it; I think that’s the only path forward for sustainability.” 

Audience Question:

Have you had to outsource services on a study you worked on in the past? What are some of your outsourcing successes or failures?