1. CBI - Clinical Trials Budgeting and Forecasting
Central Lab Budgets
CBI - Clinical Trials Budgeting and Forecasting
February 9, 2016
Kelli Isaacs

2. Agenda Central Lab Budgets – What’s Required
Moving from Proposal to Contract
Hitting Kits on Site Date - Key Milestones
Budget versus actuals and forecasting
Best practices for including a central lab in your study
Let attendees know that we are here to help. We do not intend for this to be a selling piece. This is meant to make all aware of process and expertise. With this additional understanding across the board, we can maximize efficiencies and therefore deliver results in the best way possible.

3. “
In the past 15 years, data produced by central laboratories has represented more than 60 per cent of all data submitted in a New Drug Application (NDA). This percentage is expected to approach 80 per cent within the next several years(1). “
ACM understands the impact that central lab has on your submission.
The data collected during a clinical trial forms the basis of subsequent safety and efficacy analysis which in turn drive decision making on product development in the pharmaceutical industry.
1. Anyszek T, Hayashi E and Morrow F, Decentralising Central Laboratories, International Clinical Trials, August 2010

4. REAL QUOTES
“The protocol is almost final; can we get kits on site this month?”
“First Patient In is in 4 weeks”
“Not much testing in here so we’re thinking you should be able to set up the study quickly”
“It’s exactly like the last study”
“Can you provide a proposal for a study with 50 sites and 100 patients”
“I have everything in place, sites are set; I just need a central lab”

5. I. Building the Central Lab Budget – What’s Required
Scope of Work parameters
Timelines
Regions involved
Patient numbers
Operating Assumptions
Safety Testing only
Analytical lab involved but need kits from central lab
Cost Drivers
Logistics
TAT Time

6. Building the Central Lab Budget Proposal Checklist
Patient Breakdown
Specimen Storage Requirements
Investigator Meeting Attendance
Data Transfer Frequency
Shipping Requirements
Analytical Lab Information
SIV (Kits on Site – per region)
FPI (per region)
LPLV
Study Duration
Database Lock
Countries/Sites Breakdown
The proposal checklist is a tool utilized by ACM. It contains the key information from the RFP which helps build an accurate proposal and budget. Key items include test requirements and key project timeline dates
As much information that can be provided for each of the above areas will help build the most accurate, cost effective budget.

7. Proposal Checklist Specific Content
Laboratory Testing Fees
Specimen Storage Fees
Kit Fees
Project Setup Fees
Investigator Meeting Fees
Project Management Fees
Data Transfer and Reporting Fees
Estimated Transportation Fees
ACM uses a standard budget template with the included parameters
The more information, the better.

8. Building the Central Lab Budget Key Cost Drivers
Transportation
Real-time shipping
Using speciality couriers
Shipping estimates are blended rates based on courier/weight/stability as we typically do not have exact locations at the proposal stage
Esoteric Testing
Sensitivity of analytical methods (Qualitative vs. Quantitative)
Viability of Samples
TAT on results
STAT vs real-time
Others:
Exclusion criteria
Batch analysis vs real-time analysis???
But if endpoint for your study, and need Qualitative –do you have diabetes or not to quantitative- level of glucose, micrograms per millimeter of glucose
One of the things we try to get our clients to start at end. What are the outcomes you want, and we work back – what is the data you need.
Start with the endpoint in mind.

9. II. Building the Central Lab Budget Moving from Proposal to Contract Final Budget
Final Proposed Budget is the “best estimate” based on specifications provided.
The amount billed for is based on Actuals:
Test performed
Specimens received for storage
Kits sent
Data Transfers
Data Cleaning per requisition
Shipments
We recommend a study true-up at 20-30% of enrollment (speed of enrollment, dropout, logistics, timelines)
Proposal is a “best estimate”. A study true-up should be reviewed at an agreed upon enrollment goal.

10. Work Order Work Order Process
Typically a Master Services Agreement (MSA) is signed
Company specific – either LOI or full work order
Final protocol required, proposal update recommended
Work Order Template – typically part of MSA

11. III. Hitting Kits on Site Date: Key Milestones
Lab setup times range from 4 – 8 weeks depending on complexity of study
Final Protocol
Sponsor/CRO availability/input
Input on specification document, lab manual
Final signatures before kits can go into production, requisitions completed or database developed
Site lists a week before kits on site
Setup – Process, Timelines, Deliverables and Key Documents
Earlier we arrive at finalized specifications, the sooner we start and move study into production.

12. Setup Process Sponsor/CRO Driven 4-8 Weeks Kits Sent to Sites
Study Award
Spec Doc Finalization
Study in Production
Sponsor/CRO Driven
4-8 Weeks
Kits Sent to Sites
Determine Protocol Requirements
Key Deliverables to Ensure Setup Timeline
Set Up Procedures:
Test set up
Database Development
Validation
Kit Design
Lab Manual
Site Entry
Variability in timeline:
Status of protocol
Finalizing central lab requirements
Final site list
Contact details: CRAs
Contact details: broker and importer
Highlight that client deliverables of final protocol and final central labs requirements are key. Additionally, final site list, CRA contact info, broker and importer contact info. Kits are sent to sites based upon final site list…
Commencement of the Data Management Agreement (DMA)

13. IV. Budget Versus Actuals
Proposal/Work order best estimate based on sites/countries/patients provided.
Billed on actuals
If study parameters change on something that affects the budget (e.g. database lock extended, country change, test added, patients added, etc.), the budget should be amended to reflect the changes.
Logistics assumptions – logistics can be up to 40% of your central lab budget
Forecasting – Central lab requires study data to forecast. Central lab cannot predict what is happening in your study but can help and provide input to this process.
Interim analysis points are key to checking reality versus proposed.

14. V. Best Practices for Including Central Laboratory in Study
Timing – involve Central Lab as soon as possible even if only a synopsis is available
Ask for help early in protocol development to determine the proper testing requirements that meet your study endpoints
Sponsor/CRO review on proposal / central lab specification document to ensure understanding of what central lab is proposing versus requirements of the study
Communication throughout the process: from proposal, through contract through life of study
Actuals versus proposed: Joint review/forecast of financials or a “true-up” during the study

15. V. Summary Main feeding of central lab – INFORMATION - Timely, Early
Good information required to give you best possible proposal and most efficient work processes.
Engage us early, leverage our expertise
Ask us questions; let us make recommendations
HELP US HELP YOU – only as good as information you give us
Start at the End – what are the outcomes you want