CASE STUDY

Ensuring Success for a Clinical Event

Adjudication Process Transition

Ensuring Success for a Clinical Event Adjudication Process

Transition
Bioclinica is a global life science provider that utilizes science and technology to bring clarity to clinical
trials by helping companies to develop new life-improving therapies more efficiently and safely. With
hundreds of experienced scientific, medical, and domain experts bring unmatched insight across the
development lifecycle, from the initial protocol to post-approval. The company’s thousands of employees
serve more than 500 pharmaceutical, biotechnology and device organizations – including all top 20
biopharmaceutical companies and leading CROs – through offices in North America, Europe, and Asia.

Clinical Adjudication
Clinical adjudication utilizes a standardized method to classify subjective events by a blinded, independent
physician review committee to determine the efficacy and safety endpoints needed to analyze clinical trial
outcomes, which are critical in determining a clinical trial’s success.

The Challenge
Bioclinica was contacted by multiple clients looking for a quick and comprehensive solution to support
their active study requirements for prospective adjudication while also providing an avenue to import
previously adjudicated cases into a single platform. Their pain points, as described to our subject matter
experts (SMEs), were a common theme, but one sponsor in particular was struggling and requested
a solution from Bioclinica to support a global clinical trial program that included 30 studies for an
uncommon indication. The sponsor approached Bioclinica with the goal of transitioning all ongoing
and new projects within 60 days.

Critical challenges they faced with their current, under-performing adjudication provider:

• Budget overruns from the outsourced software solution that had more than $1M
in change orders to accommodate trial design.

• Current provider did not pass validation audits after a year of support.

• Antiquated processes with data collection on paper and manual spreadsheets,

causing compliance concerns.

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 CASE STUDY Ensuring Success for a Clinical Event Adjudication Process Transition

• Site non-compliance in that imaging source document files were sent via courier
and not properly redacted by many the sites.

• Inadequate and untimely support for sites and adjudicators in their time zones
and local language, specifically in Japan.

Rescue Studies
Rescue studies are studies that have been previously run by another vendor, whether on paper or
electronically. Questionable data quality and integrity, missed deadlines, and overall mismanagement
of trials resulting in increased costs and delays in bringing treatments to market drives sponsors to seek
out another vendor to take over the management of the study. Some studies have lasted for many years,
receiving data from multiple databases with disparate data sources confounded by very tight timelines
and frustrated adjudicators.

Questions to Ask when Selecting an Adjudication Service Provider

In choosing a vendor and vetting if they can provide a comprehensive solution for your project, there are
very important questions when performing your due diligence to help ensure a successful transition.
Consider the following:

• How do you ensure that source documents are redacted within the geographical region
in which they were obtained (i.e. EU)?

• If there are language translations involved, is that auto-routed to an EU GDPR compliant
translation service automatically?

• How do you, as the sponsor, have visibility into the progress status, including overdue source
documents and open queries?

• Do you have a 24/7 support team that covers all time zones and is multilingual?

• Does your clinical adjudication system ensure proper routing of cases to the correct adjudicator
and auto-route discordant ones for secondary review, or is it a manual process?

• In your current system, if you have a configuration change order to the software, is there an
additional charge? What is the lag time on development changes?

• Does your adjudication system automatically have alerts for overdue adjudication, reminders
for the adjudicator, and automatic escalations to the project manager?

• How many clinical adjudications-experienced project managers do you have on staff, and what are
their years of experience?

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 CASE STUDY Ensuring Success for a Clinical Event Adjudication Process Transition

Does your system provide customized sponsor KPIs by study, program or event type, and by site
that is also accessible in real time?

Bioclinica’s Solution
A transition plan including clear lines of communication are the foundation for this success as well
as included regular meetings with the project teams and development teams. Bioclinica provided a
dedicated Program Manager to oversee the platform startup and transition data transfer of legacy
cases. A project manager was specifically assigned in Japan to support regional regulatory
requirements for adjudicators, facilitate consensus reviews for adjudicator meetings, payments to
adjudicators, and hospital requirements. Bioclinica provided laptops to the adjudicators as well, as
they needed to call in from their offices due to hospital requirements and provisioned large screens,
enabling the adjudicators to see larger views of images and other source documents, which takes
advantage of the pop out functionality of our adjudication solution.

Outcome
Bioclinica delivered ahead of 60-day deadline, including:

• Customized design of adjudicator pathway and online image viewing system for active
studies for prospective and retrospective events.

• Multiple 100% dedicated PM staff within key countries including Director-level support,
Program Manager, Nurse Reviewers, Project Managers and Data Managers.

• There was a 100% electronic image adoption rate, eliminating the need to ship images
via courier.

• Complete translation of training materials into multiple languages.

The program continues to grow and is now at over 40 studies due to Bioclinica’s quick turnaround
ensuring data quality and integrity and providing global support.

Summary
When performing a rescue, one must develop a trusting relationship, must be prepared to evalu-
ate the client’s expectations and needs, provide guidance, ensure data integrity, and implement the
right people in the right positions to facilitate and deliver support. Bioclinica’s facilitation of rapid
rescue embodies these elements and keeps the fast pace for approvals going strong.

For more information please contact Kathleen Dowell, Sr. Director Clinical Adjudication
and Eligibility Services Kathleen.Dowell@bioclinica.com or bioclinica.com/contact.

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