An eBook highlighting the Cloudbyz Clinical Trial Budget Management Solution, built on the powerful Salesforce platform.

1. Clinical Trial Budget & Payment
Management Solution
Digitize clinical trial budgets and payments
management and bring therapies to market faster

2. Overview
Today’s clinical trial landscape is saturated with vendor-outsourced trials, generating multimillion-dollar
program budgets for sponsors. The constant reported budget swings and cost overruns puzzle senior
leadership.
Due to the inherent complexity of clinical trials, their budgets are unique and difficult to predict and
manage. A trial budget changes constantly, much like the clinical trial itself. A majority of sponsors
struggle with managing trial budgets internally with accuracy and consistency, and many budget
managers are not well-versed in how to track financials effectively.
Many sponsor companies are failing at managing forecasts and accruals effectively for their trials. Most
companies are either holding on to too much money in their programs or they are continuously trying
to dig up additional funding to ensure a program moves forward. Both scenarios can significantly limit
organizations when it comes to funding other opportunities.
Sponsor companies also struggle with fluctuations in their trial forecasts from quarter to quarter, or
even month to month. Funding is requested and approved based on a communicated estimate but the
estimate is soon identified as being inaccurate and financials need course correction. This is a problem
that will capture the attention of senior leadership and auditors if you are a public company. It is also a
scenario that will have many internal functions anxious about the organization’s ability to manage
financials.

3. Overview
The overall trial budget is an accumulation of costs from CROs, research sites, labs, and various other
vendors. This creates a complex, time-consuming financial management rubric. There are delays in site
and subject recruitment, protocol amendments that add additional clinical assessments, scope of work
modifications with vendors, dropped and added sites and challenges of subject participation in multiple
geographies. All of these changes can significantly impact the original budget, leaving a gap in the
ability to accurately forecast and compare against the original budget with the actual trial site
activation, enrollment, and study activity expenses. As actuals replace estimates, getting an accurate,
real-time picture of what the re-forecasted expenses will be is incredibly difficult.
Manual tracking is nearly impossible and rough estimates are always incorporated. Neither the Finance
department nor the clinical staff is well-equipped for this responsibility due to gaps in data, unhelpful
vendor reports, and spreadsheets tainted with historical entry errors. The result is accruals that become
less of a reflection of actual work completed, and more of an estimate of what various people think may
have taken place the previous month.
Cloudbyz Clinical Trial Budgets & Payments management solution eliminates the constant errors which
accompany these manual updates. One central system where vendors input information simplifies this
process. Partnering with vendors who share data access and report on budget-to-actuals adds
significant value when the common goal is staying on top of a trial budget which ensures alignment,
understanding, and transparency across the systems.

4. Clinical Trial Budget Challenges
01 Delayed negotiations due to lack of transparency in relating budgets to
the study protocol. The terms and processes by which investigative sites
are paid to conduct clinical trials have impacted clinical research sites’
ability to focus on conducting quality research and meet enrollment goals
02 Sites expressed particular frustration around the line of communication
with sponsors/CROs on financial matters. Sites would prefer collaboration
with the CRO or sponsor, who manages all payments across multiple
studies.
03 Sponsors and CROs relies highly on manual and disconnected process for
investigator payments and forecasts via spreadsheets. These are time and
labor intensive, highly prone to errors, and inflexible. Delayed, incorrect or
confusing payments can alienate study investigators and site staff and
increase the risk of missed timelines and budgets. Unhappy investigators
also are less likely to participate in future studies.

5. Clinical Trial Budget Challenges
04 Inaccurate and delayed payments to sites creating potential compliance
issues and extensive reconciliation resulting in delayed study data
collection for database lock.
05 Inability to perform payments as a result of budgeted & planned visits and
ad hoc costs not aligned to planned budget & required amendments to
CTAs adds to further study delays which leads to reduced turnaround
times leading to delay in site activation timelines and patient enrollment.
06 Lack of insights past study budget and payments sets future precedents
for unreasonable budget negotiations and increasing costs

6. Clinical Trial Budget & Payment Management Solution
Cloudbyz Clinical Trial Budget & Payment Management solution helps sponsors and CROs gain
visibility, insight, and control across clinical trials and studies budget & financials. The solution helps in
accelerating study budget management with high level of accuracy with faster cycle time.
Budget management is based on activity based planning with ability to define budget templates
based on in-house research, outsources or combined and also support study specific or site specific
budget. Budget management also supports ability to define costs as per protocol site visit plans and
procedures to calculate unit costs and aggregate to study or site level covering number of subjects,
sites, IRB and site pass through costs.
Provides capabilities to track Payments and invoices and roll-up payments automatically to site level,
region level, study level and provide planned vs budget for real-time budget management.
Real-time and integrated clinical trial budget & payment management solution built on
Salesforce.com platform enables efficient collaboration between sponsors, CRO and sites creation and
management of budgets and payments across planning, start-up, conduct and closeout.

7. Clinical Trial Budget Management
MSA, MRA &
Budget Templates
Reusable templates to drive
efficiency & accuracy.
Study & Site
Budgets
Ability to generate study level &
site level budgets with real-time
collaboration.
Payments &
Invoices
Ability to generate payments
automatically and/or manually
upon completion of tasks, visits
& procedures
Forecast &
Accruals
Ability to create real-time reports
and analytics for forecasting,
accruals, variance etc
01
02
03
04

8. Introducing: Clinical Trial Budgets & Payments Solution
Cloudbyz Clinical Trial Budget & Payment Solution is built on scalable and
flexible Salesforce.com supports multiple devices, languages and currencies
Achieve accurate
forecasting with real-time
collaboration between
Sponsors, CRO and
investigators to reduce time
delays, faster study start-up,
improve accuracy, efficiency
and improve investigator
experience & satisfaction

9. Clinical Trial Budget & Payment
Management solution on Salesforce.com
End-to-end
digitization of
clinical trial budget
and payment
management
Integrated clinical trial budget &
payment management solution built
for real-time collaboration between
Sponsors, CROs and Sites to achieve
efficient and quality research and
bring therapy faster to market.

10. MSA, Rate Card & Budget Templates Templates
Reusable Budget Templates
MSA / MRA Templates
Standard Tasks & Fees
Standard Procedures & Fees
Cloudbyz CTMS provides ability to setup reusable templates such as
budget templates, sponsor and site specific MSA & MRA rate cards,
standard tasks & fees and standard procedures and fees which help
creation of budgets from template which reduce complexity, save time
and improve efficiency

11. Clinical Study - Financials
Clinical Study Financials
Management
Real-time visibility of clinical study financials both planned and actuals.
Site level budgets and payments are rolled-up to study level in real-time.

12. Clinical Study - Visit Plan
Study Visit Plan
Ability to set up study level visit plan with number of visits, procedures for
each visit from master list and add tasks and occurrences such as PI fees,
coordinator fees etc for each visit. Once setup, visit plan is used for
budgeting to calculate per subject costs and roll-them up to sites and
study level. Visit plans are also used to auto generate subject visit,
procedures and corresponding payments.

13. Study Budget - Investigator Grants
Study Budgets
Ability to create study budget covering investigator grants/site budgets,
study management fees, study meetings etc. Number of planned sites,
estimated subjects enrolments are automatically selected and provides
ability to add indirect cost % as well. Investigator grants/site budgets are
automatically populated.

14. Spotlight on desktop
Study Management Fees
Ability to add study management fees as budget line item which include
selection visit, feasibility analysis, contract negotiations etc and specify
number of units, unit costs and unit (per study, per site, per hour etc).

15. Study Budget - Study Meetings
Study Meetings
Ability to capture study meetings line items such as investigator meetings,
teleconference, face to face meetings etc.

16. Study Budget - Summary
Study Budget Summary
Ability to view study budget summary which brings all calculations
together from each line items and shows total summary budgeted cost
including indirect cost.

17. Clinical Site
Clinical Site
Ability to track and manage clinical site including budgets, collaboration,
start-up tasks and milestones, site team etc.

18. Clinical Site Budget - Invoice Items
Site Budget -Invoice Items
Ability to create site budget/investigator grant with budget lines including
invoice items, start-up fees, subject fees etc. Budget creation process also
include number of subjects planned automatically and allows to capture
indirect cost percentage and withholding percentage.

19. Clinical Site Budget - Start-up & Pass
Through Fees
Site Budget - Start-up Fees
Ability to capture start-up and pass through fees such as selection visit,
IRB fees, site selection etc and capture unit cost, number of units and
units such as per site, per hour etc.

20. Clinical Site Budget - Subject Costs
Site Budget - Subject Cost
Ability to capture per subject costs by visit and procedures units and costs
based on visit plan schedule and roll-up the total subject cost based on
planned subject enrollments.

21. Clinical Site Budget - Summary
Site Budget Summary
Ability to view site budget summary including subtotals for each budget
line and indirect costs.

22. Clinical Site - Milestone Tracking
Clinical Site - Financials
Ability to track site financials including budget tasks and corresponding
payments and view all real-time collaborations in one place.

23. Clinical Site - Budget Summary PDF Report
Site Budget PDF
Ability to generate site budget PDF which include all financial budget
details. Site budget can also be exported to Microsoft Excel pre-formatted
to show line item details and clear formatting of subject costs by visit
schedule. Generated PDF and Excel documents can be included in CDA
and collaborate with sites in real-time via investigator portal

24. Clinical Site - Invoice PDF
Site - Payments & Invoices
Ability to generate invoice PDF document for the payments generated.
PDF also include taxes if applicable.

25. Clinical Site - Payments
Payments
Ability to generate payments manually as well as automatically when
certain conditions are met such as site activation, SQV completion, subject
visit completion, task or milestone completion etc. Central place to view
all payments across studies and sites which can be further segmented via
listviews based on various criteria such as study specific, site specific or by
status etc

26. Clinical Site - Payment Detail
Payments
Ability to track payment details such as site number, study, payee
withholding, tax rate, amount, tax amount and status .

27. Clinical Budget - Dashboards
Reports & Dashboards
Ability to gain real-time visibility via reports and dashboards. User can
create reports and dashboards with point and click and drag and drop and
apply various criteria.

28. Clinical Budget - Payments Dashboards
Reports & Dashboards
More than 200+ pre-built reports and dashboards across study planning,
start-up, conduct and close out including detail reports and dashboards
on budgets, tasks, payments & invoices.

29. Investigator Portal
Investigator Portal
Integrated investigator portal provides Sponsors and CROs to collaborate
with investigators and sites in real-time across planning, start-up,
budgeting and CDA process, site activation, study conduct and close out
helping faster site feasibility, selection, budget and contract negotiation,
activation and close out .

30. Visit/Procedure Review & Payment
Generation
Subject Visit Completion
Review
Ability for CRA to review subject visit completion once site has completed
a subject visit and upon review, payments can be auto generated for as
per budget and CDA contract..

31. Real-time Status & Collaboration with Sites
Real-Time visibility to Sites
Sponsors and CROs can provide real-time visibility to sites on various
items such as payment status and capture Adverse Events, Protocol
Deviation, Manage Visit Schedule and investigators can submit payments
request via portal in real-time.

32. Real-time Status & Collaboration between
Sponsors & CROs
Sponsor Portal
CROs can collaborate with Sponsors in real-time across study planning,
start-up, conduct and closeout..

33. Real-time Status & Collaboration between
Sponsors & CROs
Sponsor Portal
CROs can provide real-time visibility to Sponsors on the studies they
collaborate on site activation status, subject enrollment status, budgets
and financials and many more..

34. Payment Forecast & Accrual Report
Forecast & Accrual Report
Ability to create real-time forecast, accruals and variance reports.

35. Actual vs Planned Budget Report
Planned vs Actual Financials
Gain real-time visibility on planned vs actual financials across
studies.

36. Spotlight on mobile
Available on mobile
devices
Cloudbyz CTMS Solution is built on
Salesforce Lightning, a mobile first
platform. Solution is available on mobile
devices as native app or mobile web.

37. Spotlight on tablet
Available on
Tablet and IPad
Solution is available on IPAD and
tablets.

38. Customer Success Story
AmerisourceBergen
OVERVIEW: AmerisourceBergen is a leading global healthcare
solutions company. IntrinsiQ Specialty Solutions was founded to help
practices navigate the complexities of specialty care by delivering
solutions that help improve practice financial performance, increase
operational efficiency and enhance patient care.
THE CHALLENGE: AmerisourceBergen was using rigid and inflexible
technology and disconnected MS word based forms via manual
process for complex clinical trial budget and payments
management which resulted in very slow, inaccurate and
inconsistent budget & financial management. Unable to scale to
meet the company growth prospects in clinical trial business.
THE SOLUTION: Cloudbyz has implemented Budget & Payments
solution on Cloudbyz CTMS to digitize clinical trial budget and
payment management across sponsors and sites in real-time.
Cloudbyz CTMS solution helped AmerisourceBergen to scale and
build better relationship with sites and sponsors working
collaboratively across clinical trial study operations and improve
business performance
BENEFITS: Faster study budget planning in collaboration with
sponsors and sites helped faster site activation resulting reduced
overall clinical trial duration. Transparent collaboration and visibility
on payments to sites and accrual to sponsors helped to build better
relationship with investigators and sponsors. Reduced inaccuracies
and rapid scaling to handle hundreds of sites with accurate financial
planning and improved satisfaction from sites due to improved user
experience.

39. Contact Us!
Ph: 312.763.8040
Email: info@cloudbyz.com
Web: www.cloudbyz.com