Building a Fully Digital,Decentralized
Research Operationfrom the Ground Up
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From “Capable but
Overlooked”
to Sponsor-Trusted
Research Partner
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Site Profile
The site had strong investigators and patient access but lacked the technology, workflows, and systems needed to support modern clinical trial execution.
01
Independent Clinical Research Site
An independent research site with strong investigators and patient access, operating without a unified digital infrastructure.
02
Manual Operations in a Digital Trial Environment
No CTMS in place, a traditional on-site only visit model, and growing sponsor demand for decentralized and hybrid trial capabilities the site could not yet support.
03
Capability Without Infrastructure
While clinical execution was solid, the site lacked the technology, workflows, and systems needed to support modern trial models limiting scalability and sponsor opportunities.
The Reality Before Trial Aid
Operations were functional but entirely manual. The site knew digital transformation was necessary but didn’t know where to start without disrupting ongoing studies.
01
No CTMS in place to track studies, finances, or milestones
02
Study data lived across spreadsheets, emails, and paper files
03
No standardized workflows connecting regulatory, clinical, financial, and recruitment teams
04
Decentralized trial requests from sponsors could not be supported
05
Physical exams required in-clinic visits only, limiting patient reach
06
Leadership lacked real-time visibility into study status and capacity
How Trial Aid Got Involved
The site contracted Trial Aid to design and implement a complete digital and decentralized operating model, acting as an extension of operational leadership.
Trial Aid’s mandate was to:
01
Prepare the Site to Conduct Decentralized and Hybrid Clinical Trials
Trial Aid designed compliant operating models that enabled remote, hybrid, and in-clinic visits to function together allowing the site to meet sponsor requirements without disrupting ongoing studies.
02
Introduce Technology to Support Remote Physical Exams at the Clinic and Patient Home
Trial Aid implemented and governed technology that enabled high-quality remote physical examinations, expanding patient reach while maintaining clinical standards, documentation integrity, and regulatory control.
03
Implement and Operationalize a CTMS from Scratch
Trial Aid selected, configured, and embedded a CTMS as the site’s central system of record connecting study tracking, milestones, and financials to daily operations rather than treating it as a standalone tool.
04
Digitize Workflows Across All Departments
Trial Aid transitioned regulatory, clinical, financial, and recruitment workflows into standardized digital processes improving traceability, coordination, and real-time visibility across the organization.
01
Decentralized Trial Workflow Design
Trial Aid first designed compliant decentralized and hybrid workflows mapping eligibility, visit types, data capture, staffing responsibilities, and regulatory oversight.
Technology was implemented only after workflows were clearly defined, ensuring systems supported operations rather than dictating them.
32%
44%
53%
21%
27%
02
Remote Physical Exam Technology
Trial Aid implemented technology enabling remote physical exams both in-clinic and at patients’ homes while maintaining clinical quality and regulatory control.
Staff were trained on appropriate use, compliant execution, and accurate documentation expanding patient access without compromising data integrity.
2
+
2
4
+
4
8
+
8
16
+
16
03
CTMS Implementation & Workflow Integration
With no CTMS in place, Trial Aid selected, configured, and implemented a CTMS aligned with site workflows.
Study tracking, milestones, financials, and reporting were centralized, and staff across all departments were trained making the CTMS the system of record.
87K
27%
04
AI
Integration
AI-driven tools were introduced to support faster data review, internal quality checks, patient pre-screening, and organized document management.
AI was deployed with defined governance and human oversight enhancing efficiency without introducing compliance risk.
05
Full Digitalization of Operations
Trial Aid transitioned the site toward fully digital operations, including document management, standardized workflows, reduced paper dependency, and improved traceability.
Staff were trained not just on tools but on how digital systems support quality, compliance, and scalability.
06
Staff Adoption & Operational Governance
Change management, training, and accountability structures ensured staff adoption, consistent use, and long-term sustainability preventing technology from becoming shelfware.
What Changed
The Results the Site Actually Felt
An operations lead shared:
“We went from paper and spreadsheets to a system that actually connects everything we do.”
Ability to conduct decentralized and hybrid clinical trials
01
Expanded patient access through remote physical exams
02
Centralized study and financial tracking via CTMS
03
Improved coordination across all departments
04
Faster data review and patient pre-screening
05
Are You Ready to Transform Your
Research Site?
Contact us and request a free consultation today!
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