GUIDE NOVEMBER 2020

The Decentralized
Clinical Trial Playbook
About this playbook
Decentralized Clinical Trials (DCTs) are getting much attention due to recent
global events. The need for trial continuity in a world of restricted movement and
distancing has disrupted the traditional location-centric clinical trial model, and
DCT technology is the enabler. Though DCT technologies have existed for several
years, they are now at the forefront.

This playbook is a tool for sponsors and CROs who want to leverage DCT
technology to support remote interactions in their clinical studies. We hope this
playbook helps your selection, planning, and prioritization as you move into the
exciting world of DCTs.

In this playbook

• Learn which study areas leverage DCT technology

• Identify key DCT tools

• Learn why Castor is your DCT technology solution

• Other DCT considerations including support, training,

communications, and IRB approvals

• Seven steps to getting started with a DCT technology partner

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Study areas that leverage DCT technology

If you are reading this, you likely already understand the high-level benefits
that DCTs can provide. But certain study areas benefit more directly from DCT
technology. You don’t need to apply technology to each area, especially when just
starting, but understanding which areas are an option is helpful.

• Enrollment – Recruitment and enrollment are significant challenges for clinical

trials and are often the cause of delays and unexpected extra expense. Using
digital methods to recruit, enroll, and get consent can increase the chances of
success for a trial by saving time and money; and can provide other benefits
such as reaching a broader and more diverse participant group. eConsent is a
pivotal technology for remote enrollment because it lets participants use their
own devices from home, further reducing the need for sharing and sanitizing. In
today’s world of rapid changes, seeking remote re-consents for participants in
ongoing studies is another benefit that eConsent can offer.

• Patient experience - Ensuring that the participant and patient experience in a

trial are as burden-free and straightforward as possible is a goal that contributes
to trial success. When a participant’s experience is optimized, they are more
likely to stay in a trial. A key enabling technology that enhances participant
experience is electronic patient-reported outcomes (ePROs), which can be
completed using a participant’s computer or smartphone and has robust
reminders and notifications to keep participants in compliance with timely trial
task completion.

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• Trial visibility – A critical trial success factor is the ability to focus on the study’s
operational oversight. Trial activity dashboards keep the study team in sync
with study activities and help keep study conduct on track. When every study
activity is captured and presented on role-based dashboards, study activities
stay top-of-mind and are more likely to get done. This oversight helps keep
trial timelines on track and can even increase the chances that they can be
accelerated.

• Data capture – Clinical technology offers new and powerful ways of collecting
data. For DCTs, the ability to capture data in real-time continuously from
multiple sources while managing a substantial amount of data is of primary
importance. Having a robust data model and data capture technology improves
data quality in many different ways. Remote electronic data collection on an
enterprise-grade platform that includes regulatory considerations for in-home
data collection is critical.

• Monitoring - Purpose-built remote trial monitoring solutions enable CRAs

to review documents and conduct oversight activities without being in the
physical site. CRAs can spot problems and trends more efficiently to improve
quality with direct access to regulatory and source content. Besides, higher-level
metrics, such as safety issues or turnaround times, can be more easily identified.
A combination of processes and tools provide the optimum level of remote
monitoring. CRAs can perform remote monitoring activities and support the
site monitoring plan. Deploy centralized monitoring resources to assist where
needed.

• Compliance - Regulatory considerations for applying remote technologies

in DCTs are not unique compared to traditional trials. Still, there is a need to
use existing regulations in a new environment. Those considerations will vary
based on the disease area, the type of investigational drug, and the types of
trial activities that are decentralized. In the context of a virtual or decentralized
clinical trial, the Health Insurance Portability and Accountability Act (HIPAA)
covers all data collected during the trial, including from mobile devices.

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DCT Tools
The specific digital technologies used for data collection vary by study and include
telemedicine, wearable/sensor devices, eConsent, electronic clinical outcome
assessments (eCOA), and electronic health records (EHRs). Mobile technologies
include data collection vehicles such as electronic diaries and wearable sensor
devices. In-home services allow the collection of vitals such as blood pressure and
blood samples. Let’s look at how Castor’s DCT tools align across DCT technology-
ready areas of a trial.

Enrollment

Castor strives to set the standard for the industry by enabling our customers to
recruit, screen, and consent participants through a customizable digital enrollment
workflow. Participants sign up through a study-specific recruitment landing page
and receive an invitation to Castor eConsent. Once registered, they can provide
additional information to help with the study team’s screening activities and
review and sign their Informed Consent form. The consent process can include ICF
comprehension questionnaires and/or be followed by an automated ePRO survey.
Castor eConsent can be integrated directly with Castor EDC for each research
project minimizing administrative overhead and ensuring visibility over the study
progress.

• Flexible enrollment flow with optional comprehension and screening

questionnaires. Integrated with Castor EDC for real-time subject and study
progress
• Maintain face to face engagement with fully remote consent using secure video
calling
• Custom recruitment landing page per research project
• 21 CFR Part 11 compliant
• Reduced administrative burden and nonconformance/compliance risk/
adherence to ICF process at sites
• Castor’s enrollment portal makes the entire process, from recruitment to
electronic informed consent, straightforward and automated.

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Patient experience

Capture data at the source: the patient. Wearable devices open a whole new world
of patient data capture convenient for the patient and allows you to collect more
data. These wearables also allow real-time data capture, which can provide you with
more frequent, and earlier indications for patient safety issues and other insights
that can allow you to adjust work on the trial in flight if needed.

You can capture another type of patient data with electronic patient-reported
outcome (ePRO) technology. Design, edit, and send ePROs with Castor’s intuitive
platform, seamlessly tracking survey distribution and retrieving responses.
Save valuable time spent integrating data from multiple sources by connecting
all clinician, patient, and device data at an individual record level. Castor ePRO
provides a complete overview of all data, including granular audit logging.
Build ePRO surveys with Castor’s form builder, or import them from our Form
Exchange. You can bundle surveys into packages to share with recipients via email.
Develop ePRO and Patient Dictionary mobile apps to support more specific study
needs (eCOA). Send individual or multiple invitations either immediately, at a later
date, “yet to be defined,” or at a scheduled date and time. Check the progress of
your requests, send survey reminders, or analyze responses as they come in.

• Streamlined patient communication

• Reduced barriers to participation such as inconvenience and costs of traveling to
sites facilitated by telehealth visits, eConsent, and ePRO
• Participant platform with integrated questionnaires
• Wearable and connected devices for patient data capture are more convenient
for the patient and allow sponsors to collect more data.
• Intuitive, user-friendly multilingual interface
• A growing suite of apps including a COVID-19 Symptom Tracker

Castor’s ePRO solution and ability to integrate with

multiple devices, wearables, and apps make it easy
to collect and continuously update research data
for your decentralised and hybrid trials.

Visit website

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Trial visibility

Effortlessly monitor and manage your research participants throughout the study
lifecycle. Progress dashboards enable you to identify issues rapidly and trigger
actions on time.

• Participant monitoring and management throughout the study lifecycle

• Real-time reporting
• Patient progress dashboards
• Document management
• Study health dashboards
• Milestone tracking
• Amendment tracking

Data capture

• Easily collect and store data from diverse sources with Castor EDC. Our robust
API enables data collection directly from other systems and IoT enabled devices.
• Import lab data and EHR/EMR data using HL7 FHIR messaging.
• Take periodic measurements
• Connect devices and wearables like scales, home pulse oximeters, and
thermometers through our API
• Capture survey data from ePRO, eCOA, ePerfO, Elinor, and eObsRO forms

Monitoring

Castor supports onsite, remote, and centralized monitoring practices with its cloud-
based platform and a robust suite of automation tools designed for hybrid and
decentralized trials. Automatically generate queries with our automation engine,
perform source data verification (SDV), view subject progress dashboards, and
create custom data review and verification types.

• Cloud-based system accessible from anywhere

• Granular user permissions for flexible user rights set up
• Submit and track amendments
• Manage study team documentation and track eTMF progress.

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Compliance

Castor software is compliant with all relevant regulations, including Good Clinical
Practice (GCP), FDA 21 CFR Part 11, and Annex 11. Collect data for decentralized
and hybrid trials with confidence, knowing you’re doing so in a secure and compliant
manner.

• Compliant with ICH-GCP E6, FDA 21 CFR Part 11, and EU GMP Annex 11
• ISO 27001 and ISO 9001 certified
• Enables ISO-14155 compliant data management
• Supports GDPR compliant studies at European sites
• HIPAA-compliant servers in the US
• Global servers allow compliance with local privacy and security regulations.

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Castor is your DCT technology solution.
To run a DCT, you need modern enterprise-grade technology. Castor is the
top-rated Electronic Data Capture (EDC) system. Castor’s EDC, ePRO, eCOA,
eConsent, eSource, and eTMF solutions enable researchers to easily capture and
integrate data from any source and decentralize their trials. Highlights: Build studies
within hours leveraging pre-built templates; Integrate EMR/EHR, patient, clinical,
and device data; we find that clients build and pass UAT for 90% of studies in Castor
in less than four weeks, significantly faster than the industry benchmark.

Castor at a glance
• The top-rated EDC system

• User-friendly technology

• Reduce study build time

• Decentralize your trials

• Capture data from any source

• Run efficient multi-center studies

• World-class support and professional studies

• FDA 21 CFR Part 11 compliant

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Castor has clinical experience.

Castor contains the core EDC functionality you need

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Castor supports the entire
clinical research process.

Castor has happy clients

“It was impossible to conduct this type

of trial without an API integration.”

- Peter Christian Gaarde, Software Development Engineer at RSP Systems

RSP Systems solved the problem of disparate clinical data capture with a
single, centralized EDC platform. Using Castor EDC, they are now able to
seamlessly capture clinician, patient, device, and any other external data and
get a complete overview of all the data linked to an individual patient.

The ability to send data directly from a patient’s home into the Castor EDC
database enables RSP Systems to not only accomplish a lot more in a short
time but also provides them with controlled access to their study data.

Read the full success story here Other success stories

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Castor is the best-reviewed platform in the industry.

Mark Twain famously said, “I can live for two months on a good compliment.” We
believe in that sentiment and are grateful for all of the great feedback we’ve gotten
from our clients. Check it out here.

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Other DCT considerations
Of course, DCT planning goes beyond technology. Other factors to consider:

• Support participants and site staff throughout the clinical research journey
to ensure your DCT’s success. Sites need help with participant identification,
engagement, recruitment, and associated study and site activities. Participants
need to have the comfort of knowing they can get advice with trial activities and
with technology.

• Training - Investigators should articulate procedures and train staff on

processes unique to DCTs. For example, trial participants must know what to do
in the case of experiencing an adverse event. For study startup, remote SIV and
IM training is key to DCT success – as well as the ability to maintain automated
role-based assignments and compliance tracking.

• Communication – Having tools to connect with site staff remotely to meet

training and support needs without removing collaboration is a critical
consideration. Planning for communications processes in trial planning will also
help to ensure success.

• IRB Approval – DCTs are not held to a different standard than traditional
clinical trials with regard to investigator delegation and oversight. But DCTs may
require additional considerations for potentially enrolling increased participant
populations, and for participants that may be geographically distant from the
investigator and research team. The study protocol should clearly identify
the trial team’s roles and responsibilities in accordance with applicable FDA
regulations such a 21 CFR parts 11, 50, 54, 56, 312, and 812.

It is essential that sponsors partner with CROs and technology vendors with proven
experience in running successful DCTs to help them navigate their DCT journey.

Don’t forget about support, training, communication, and regulatory

guidance. The right technology partner can guide you through this planning
as well.

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Seven steps to getting started with a DCT
technology partner
Your flow may be slightly different, but these are the general steps to start your
engagement with a DCT technology vendor:

1. Share your research, business/operational goals with your vendor.

2. Assess their tooling and support to help you achieve your goals

3. What is their experience in the DCT space, and

4. Ability to adapt when the inevitable bumps occur during implementation.

5. Agree on timelines and dependencies on definitive requirements,

implementation, and onboarding.

6. Establish an engagement framework for support, account management, and

product feedback.

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Recap

• The time is now to incorporate DCT technology into your clinical

research.

• The critical areas of DCTs are enrollment, patient experience, trial

visibility, data capture, monitoring, and compliance.

• Technology enables DCTs, so you need a reliable technology partner

to execute a successful DCT.

• Castor is your DCT technology solution.

• Consider support, training, and communication.

• Follow the seven steps to getting started.

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About Castor

A global health tech company, Castor enables manufacturers and research

organizations to maximize the impact of data through clinical trial automation and
data reuse, while supporting a patient-centric, decentralized approach to research.

Castor’s platform has supported more than 4,100 commercial and academic
studies that cover a broad range of disease areas including oncology, diabetes,
cardiovascular disease, central nervous system, rare diseases, and infectious
diseases.

Castor’s capabilities include:

Electronic Data Capture (EDC) to maximize productivity in clinical studies and

integrate data from different sources

Electronic Patient Reported Outcome (ePRO) forms to administer surveys and

collect clinical data into a centralized platform

Integrations to capture data directly from multiple sources, including patients,

clinicians, devices, wearables, and EHR systems

eConsent to facilitate and automate patient enrollment processes

Services for study set up and study conduct to help reduce study build time,
capture higher quality data, and get to market faster

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