Five Quick Tips
to Accelerate Your Study Build
Copyright 2022 Medidata Solutions, Inc., a Dassault Systèmes company

Accelerating study build times became an imperative
during COVID-19. Delivering faster study builds has
since propelled the adoption of new technology,
processes, and resources.
Study build teams are required to simplify and future
proof design to save downstream time and costs.
They also have an opportunity to gain greater control
of study data and execution, optimize the entire trial
lifecycle, and accelerate time-to-market.
While speed prevails, study build teams need toensure study integrity, patient safety, and regulatory
requirements. The technology strategy they choose,the approach they take, and the specialists theypartner with drive the pace, data integrity, andsuccessful outcomes of their trials.
This eBook outlines five specific tips you can apply
to accelerate and optimize your study builds today,
and into the future.

TABLE OF CONTENTS
UNDERSTAND NEW STUDY BUILD CHALLENGES3

TIP 1: REQUIREMENTS GATHERINGAND KICKOFF4

TIP 2: STANDARDIZE STUDY BUILDS5

TIP 3: WORKABLE STUDY DESIGNCOLLABORATION

6TIP 4: LEVERAGE TECHNOLOGYBEST PRACTICES

7TIP 5: CHALLENGE THE STATUS QUO

8BUILD TO ACCELERATE TIME-TO-MARKET

9Author and Contributor

Jeff Boehm
Vice President, Implementation
Consulting Professional Services
Medidata

FIVE QUICK TIPS TO ACCELERATE YOUR STUDY BUILD

2Study builds are core to ensuring the integrity
and accelerating the pace of clinical trials.
Yet, new challenges can affect the qualityof a build and impact the outcome of a trial.
Always faster
The first challenge is continuously shrinking timelines. Everyonewants faster builds. Increasingly complex builds are expected tobe completed in less time and with fewer resources.

More integration requirements
As a result of the COVID-19 pandemic, study build teams are being
asked to respond to quickly increasing decentralized clinical trial(DCT) requirements. Those lead to complex integrations across anever growing number of systems trying to communicate with eachother. To ensure data integrity, more vendors require alignment,
defined roles and responsibilities, additional documentation,and often challenging orchestration across time zones.

Adjusting to adaptive trials
Study build teams are also faced with adjusting to adaptive trials,
which require changing a trial design based on the data being
captured and analyzed, leading to changing protocols.

UNDERSTAND
NEW STUDY BUILD
CHALLENGES

As a key part of design requirements for databases, protocols need
to be built so they can evolve in a flexible manner while ensuring
electronic Case Report Forms (eCRFs) can be captured accurately
and efficiently.

FIVE QUICK TIPS TO ACCELERATE YOUR STUDY BUILD

3

1

TIP ONE

REQUIREMENTS GATHERINGAND KICKOFFPLANyMeet to initiate projectyGather requirementsyDefine critical success factors

yy

Establish sponsor project team,responsibilities, and working
relationships
Develop program, schedule,and communication plan

Database
Requirements

Integration

Timelines

Resources

While timelines are becoming tighter thanever, get your study build off to a strong startby investing enough time in the requirements
gathering kickoff.
Spending the right amount of time upfront
will ensure avoiding errors and delays indownstream configuration. While the main
focus tends to be on the ‘first patient in’ goal,
requirement gathering and kickoff planning
can not be rushed.
Achieving a higher degree of timeline successrequires you to:

AdaptiveTrials
Protocols

Measure twice.
Cut once.

Decentralized
TrialsEnsure all stakeholders participate
All parties must be included in kickoff meetings.
Avoid proceeding without your key partners
or vendors responsible for different areas ofintegration/delivery. When everyone is at thetable from the start, key decisions do not need
to be revisited.

Set detailed expectations
Define clear roles and responsibilities. Who willplay what role throughout the entire lifecycle ofthe project? Who will be responsible for testing?
How will dependencies work and evolve?

Create realistic timelines
You can create any timeline at the beginningof a project, but as the trial evolves, an activity
can get delayed or a vendor may miss deadlines,
cascading into downstream effects. Plan forsuccess from the start.

Clarify requirements
An internal review of requirements before
configuration takes place must be vetted upfrontby key people before they’re turned into solutions
and study build.
To avoid rebuilds and save time, ensure clear
requirements around both upstream anddownstream integrations.

FIVE QUICK TIPS TO ACCELERATE YOUR STUDY BUILD

4

2TIP TWOSTANDARDIZESTUDY BUILDSBUILD
yStudy design specification

yeCRF and single fields edit checksyyyDynamic edit checks and visit
schedule
Data validation specification
Configured edit checks andcustom functionsyClinical views

yGlobal reports

Avoid reinventing the wheel. Standardize
utilizing company standards, client standards,or industry standards, such as CDASH, to helpalign all stakeholders around a consistent way
to collect data.
Formats and structures are set to provide clear
traceability of submission data into the Study
Data Tabulation Model (SDTM). Using CDASH
delivers more transparency to regulators andothers who conduct data review.

Gain clarity in each stepOnce you select and apply a specific standard forthe course of your clinical trial, have clarity in eachstep. It will enable you to use pre-built edit checks,
load directly, and pre-test to reduce times inbuilding and testing.

Streamline and automate
Using features within a platform enables you tostreamline the build, set variables, and run checks
at different variable levels. Use dynamic features
to reduce the number of unique forms.

Leverage global libraries

Repository ofcommon forms

Reduction instudy build time

GLOBALLIBRARY
Higher reuse of eCRF
to standardize
data collection

Using global libraries simplifies study builds
and ensures that studies utilize standard forms
and processes. This results in less redundancy,
greater standardization, and faster startups todeliver timely releases.

Maximize reuse
Cost savings fromgreater efficiencies

Maximize reuse to minimize effort and testing.
It will enable you to carve out time to develop
more complex, customized pieces of work.
FIVE QUICK TIPS TO ACCELERATE YOUR STUDY BUILD

53USER ACCEPTANCETESTING / DEPLOYy

UAT checklist providedyStudy build testingyData upload testingySite communicationand trainingyFreeze legacy data entryyCutover strategy

yy

Post data upload cleaning
strategy
Minimize site downtime

TIP THREE

WORKABLE STUDY DESIGNCOLLABORATION
Collaboration isthe number one driver
for a successful build.
The mindset of “One Team with One Deliverable”
across multiple groups and organizations
will ensure transparency, accountability,and agility during study build and throughout
the trial journey. Collaboration is facilitatedthrough specific approaches.

Systematize interactive reviews
Keep ongoing interactive reviews of builds,
especially with key decision makers, to share,review, and approve each decision and step
preceding the study build.
Ongoing reviews will also accelerate formal
testing and approvals, and help move throughtimelines at a faster pace.

Reconcile differences
Consolidate findings to reconcile differences.
Many stakeholders will do testing and come up
with different results.
Using tools such as Rapid Study Builder willconsolidate findings, enable reporting, trackchanges, avoid duplicate iterative recycles,
and document full audit trails in real time.

Test end-to-end
As you prepare for User Acceptance Testing(UAT), execute an end-to-end testing of one
patient all the way through the lifecycle of theirtime on the study.
Create a patient in the system all the way
through the lock and pull out reports to mimic
production, so that when you do go live,
there are no last minute surprises.

FIVE QUICK TIPS TO ACCELERATE YOUR STUDY BUILD

64DATA CONTROL — EXTRACT,TRANSFORM, AND LOADyy

Extract data from source system
Author data transformation
scripts, as neededyTransform data into target formatsy

Map data using Batch Upload ToolyDetermine sequence of data loadyPerform dry run of data load

TIP FOUR

LEVERAGE TECHNOLOGYBEST PRACTICESProWhen your technology is able to extract whatis needed from its source system, information
is easier to access and data transformation
scripts become more efficient.
The right technology can also transform thatdata into target formats, and map it together
using a batch upload tool.

fessional Services

Patient Engagement

Medidata
Clinical Cloud
ClinicalOperations

Data
Management

Control your data
Getting the most out of your build’s workflow
means applying a basic formula for extracting,transforming, and loading your data.

Advanced
Data & Analytics

Simplify integrations

Connect everything

A single, integrated platform eliminates
multiple steps throughout the lifecycle ofyour study build and results in reducedbuild times, trial length, effort, errors,
and costs.

When your clinical systems (EDC, RTSM, eCOA, etc..)
are all connected in a unified platform approach,all process data—from patient consent to suppliermanagement—flows across the systems.
Remove additional integrations from your build’s
equation and minimize disruption.

FIVE QUICK TIPS TO ACCELERATE YOUR STUDY BUILD

7

5FUTURE-PROOF BYSIMPLIFYING TECHNOLOGYyyyyy

Design for end-to-end
implementation
Avoid unnecessary
programming and risks
Centralize and supervise
data access
Eliminate inefficiencies
around technology integration
Reduce reconciliation risks
from non-standardized data

TIP FIVE

CHALLENGE
THE STATUS QUOTimelines for clinical trials are not expanding.
If anything, they are getting shorter. And,complexity is rising.
Rather than stopping at celebrating bareminimums of meeting timelines and budget
goals, the question should always be:
how can we do better?

Embrace new technology
Is there technology that we can leverage
to be even faster and more efficient?
Complacency when it comes to evaluating
and rethinking the technology with which
we’ve become accustomed is detrimental
to ‘doing better’.
Take an iterative approach: are we reallylooking to see what happened with that
previous build and how can we be evenmore efficient going forward? Think: Global
libraries. Connected workflows. Common
system languages. Automated real-time
visibility and decision-making.

Flexing to new processes
The way we’ve always done it isn’t necessarily
the way we should continue to build studies.
The speed of clinical trials and expectationsof patients, sites, researchers, sponsors,and contract research organizations is rising
exponentially.
Initiating processes that focus on what went
wrong, in addition to what went well, will informand help define new, more efficient approaches
to study build and clinical trial execution.

Look back to move forward
Take time to do an internal process audit at
the end of a project.
Look back and see what happened to figure out
how you can gain efficiencies moving forward.

FIVE QUICK TIPS TO ACCELERATE YOUR STUDY BUILD

8Speed will continue to prevail, as expectations
to accelerate time-to-market are increasing.
Study build teams have options in technology, inprocesses, and in resources to ensure study integrity,
patient safety, and regulatory requirements.
Apply all tips shared to improve your study builds:
increasing your Library, working on a platform
approach, planning better upfront. Those areason which you can reflect to create new efficiencies
for even quicker builds will determine the successof your clinical trials moving forward.
While top-notch technology may require a higher
outlay upfront, it will help you avoid troubleshooting
down the line, hours of effort to work within disparate
systems, and platforms that don’t communicate.

BUILD TO ACCELERATE
TIME-TO-MARKETThe Study Build approach and technology
strategy you choose, the approach you take,and the specialists you partner with will drive
the pace, data integrity, and successful outcomesof your trials.

FIVE QUICK TIPS TO ACCELERATE YOUR STUDY BUILD

9FIVE QUICK TIPSTO ACCELERATE YOUR STUDY BUILD
About Medidata
Medidata is leading the digital transformation of life sciences, creating hope for millions of patients. Medidata helps generate the evidence
and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value,
minimize risk, and optimize outcomes. More than one million registered users across 1,800+ customers and partners access the world’s
most trusted platform for clinical development, commercial, and real-world data. Medidata, a Dassault Systèmes company (Euronext Paris:#13065, DSY.PA), is headquartered in New York City and has offices around the world to meet the needs of its customers. Discover more at
www.medidata.com and follow us @medidata.
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Copyright 2022 Medidata Solutions, Inc., a Dassault Systèmes company