Clinical Trial Operations and Decentralised Trials Corporate Training
Clinical Trial Operations & Decentralised Trials Corporate Training
A 24-hour instructor-led program that teaches clinical and operations teams to design, run, and oversee decentralised trials, from eConsent and remote monitoring to safety reporting and inspection readiness.
Instructor-led group trainingVirtual / on-site / off-site10 languagesDelivered inEnglish, Spanish, Mandarin, German, Arabic, Portuguese, Hindi, French, Japanese, Italian100+ countriesWe have delivered inUnited States, United Kingdom, India, Canada, Germany, France, Netherlands, UAE, Saudi Arabia, Singapore, Australia, Japan, Brazil, South Africa and 90+ more countries
How we build a inspection-ready decentralised trial team
The Edstellar CLINICAL TRIAL OPERATIONS Capability Model
Assess trial readiness
Skill checks map your team's trial operations, DCT technology, and compliance baseline.
Set shared standards
One shared playbook for eConsent, remote monitoring, safety reporting, and documentation.
Practice in guided labs
Labs cover decentralised workflows, safety narratives, and audit preparation with real cases.
Measure the lift
Lab reviews benchmark each employee's decentralised trial operations capability.
Scale across teams
One standard rolls out across clinical operations, data management, and safety teams.
Need more than one program?Get a group quote
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Program Overview: What is Clinical Trial Operations and Decentralised Trials?
Clinical Trial Operations & Decentralised Trials is Edstellar's instructor-led program for clinical operations teams, trial managers, and sponsors moving beyond site-centric studies. Over 24 hours, participants learn trial foundations and regulation, decentralised trial models and enabling technology, remote patient recruitment and monitoring, safety reporting, and vendor oversight. The program covers the full operating reality of running trials where patients are.
Participants design decentralised elements for realistic protocols, choosing which visits go remote, which technologies carry the data, and how safety oversight adapts. They rehearse patient recruitment funnels, remote monitoring workflows, and pharmacovigilance escalations in guided exercises. Instructors with trial operations experience review designs for regulatory defensibility. Six practice sessions build toward the capstone: a complete decentralised trial operating plan.
Decentralised trials promise faster recruitment and better diversity, but most sponsors bolt remote tools onto site-based processes and get the worst of both: confused patients, fragmented data, and inspectors asking hard questions. This program teaches operations teams to design decentralised trials deliberately, model first, technology second, oversight throughout.
Each team delivers a decentralised trial operating plan for a realistic protocol, model selection, technology stack, recruitment and monitoring workflows, safety reporting paths, and vendor oversight. Running trials that reach patients where they live, without losing regulatory control, is now within their grasp.
Over six modules, teams progress from trial foundations and DCT technology to a full capstone operating plan. The program emphasizes participant safety, data integrity, and documentation discipline so decentralised trials hold up under regulatory scrutiny.
What's Included in this Workshop for Your Enterprise Teams
- 1
Guided hands-on labs
Build eConsent journeys, monitoring plans, and safety narratives in labs.
- 2
Capstone project
Deliver a complete decentralised trial operating plan and defend it.
- 3
Compliance-focused practice
Every lab ties decentralised choices to inspection readiness.
- 24 hours of instructor-led sessions, onsite or live virtual
- Hybrid delivery aligned to your clinical operations calendar
- Pre-program skills assessment for each cohort
- Post-program action plan and readiness checklist
- Course materials and lab guides for every participant
- Scheduling aligned to your trial milestone calendar
Build your team's skills. Anywhere in the world.
Real-world use cases
from day one
Instructor-led training
for your teams
Delivered globally
in 100+ countries
Enterprise Training Solutions Customized for Your Company
One partner for instructor-led corporate training, delivered the way your teams work.
Request a Training Quote- Customized Training Delivery
- Scale Your Training: Small to Large Teams
- In-person Onsite, Live Virtual or Hybrid Training Modes
- Plan from 2000+ Industry-ready Training Programs
- Hands-On Labs on Live Infrastructure, Led by Industry Experts
Clinical Trial Operations and Decentralised Trials Course Topics and Program Outline
A 24-hour applied program: trial foundations and regulations, decentralised models and technology, recruitment and remote monitoring, data and safety, vendor oversight and audits, and a capstone operating plan.
Built by Edstellar with clinical operations practitioners
Built by practitioners who run and oversee decentralised trials in regulated environments, shaped around your stack and use cases.
We benchmark your team's trial operations fluency and decentralisation readiness so labs target your weakest links.
Your team learns trial foundations, regulations, and decentralised trial models through guided instruction.
Teams run guided labs on eConsent, remote monitoring, safety reporting, and audit preparation with real workflows.
Your team ships a complete decentralised trial operating plan with risk register and inspection checklist.
24 hours of instructor-led, lab-driven decentralised trial training ending in an operating plan your team can deploy.
Delivered as
Delivered hybrid, onsite, or live virtual across 3 full days or six half-day sessions, matched to your trial milestone calendar.
Guided lab: read a model protocol synopsis and map its objectives, endpoints, and visit schedule to operational tasks.
learna)Protocol structure: objectives, endpoints, eligibility, and visit schedules
b)Good Clinical Practice and sponsor, site, and IRB responsibilities
c)Regulatory pathways: FDA, EMA, and MHRA expectations for trials
d)Trial roles: CRA, CTA, data management, and vendor oversight teams
Guided lab: design a hybrid visit schedule for a model trial and select fit-for-purpose decentralised tools.
learna)Decentralised models: hybrid, fully virtual, and site-supported designs
b)eConsent platforms and remote participant onboarding flows
c)eSource, ePRO, wearables, and connected device data capture
d)Risk assessment for decentralised elements and mitigation plans
Guided lab: script an eConsent journey with comprehension checks and draft a central monitoring visit plan.
practicea)Decentralised recruitment: digital channels, registries, and referral networks
b)eConsent workflows, comprehension checks, and reconsent triggers
c)Remote monitoring: central monitors, source data review, and visit cadence
d)Participant retention tactics and burden reduction in DCT designs
Guided lab: write a serious adverse event narrative from a simulated case file and build a safety reporting timeline.
practicea)Data management for DCT: validation, queries, and database lock
b)Adverse event capture across remote channels and home nursing visits
c)Safety reporting timelines, narratives, and serious adverse event workflows
d)Pharmacovigilance signal detection from real-world and device data
Guided lab: score vendor KPIs on a simulated scorecard and draft a remediation plan for audit findings.
practicea)Vendor selection and oversight: CROs, home nursing, and technology providers
b)Quality agreements, KPIs, and escalation paths for vendors
c)Audit preparation: trial master file completeness and essential documents
d)Inspection readiness: mock inspections and finding remediation plans
Capstone lab: deliver a full decentralised trial operating plan for a simulated indication and defend it in an instructor review.
applya)Trial design brief for a decentralised indication of your choice
b)Technology and vendor stack with oversight and KPI plans
c)Risk register and mitigation plan for decentralised elements
d)Trial master file structure and inspection readiness checklist
Customize this program tailored to your team?
Tell us your training needs: what your team already works with, the level they’re at, and the topics you want them to focus on. We’ll adjust the modules, duration and hands-on labs, and send you a customized outline for your group.
Key Skills and Outcomes Your Team Will Gain
Every outcome is practiced in guided labs and reinforced in the capstone, so your team leaves ready to run decentralised trials.
Read trial protocols
Translate protocol objectives, endpoints, and schedules into operational tasks your team can execute.
Design decentralised models
Choose hybrid or virtual trial designs and match each decentralised element to its risk level.
Run eConsent workflows
Build remote consent journeys with comprehension checks and reconsent triggers that hold up in audits.
Monitor trials remotely
Operate central monitoring, source data review, and visit cadence without relying on onsite presence.
Report safety events
Capture adverse events from remote channels and write inspection-ready safety narratives on time.
Oversee vendors
Manage CROs, home nursing, and technology providers through quality agreements, KPIs, and escalations.
Pass inspections
Keep trial master files complete and respond to audit findings with structured remediation plans.
Teams that Benefit from this Clinical Trial Operations and Decentralised Trials Group Training
Built for clinical operations, data management, pharmacovigilance, and quality teams that run or oversee decentralised trials. Content adapts to role and experience, so each cohort practices the workflows it owns.
Run decentralised trials with confident operations
Give clinical operations teams the playbooks to design, start up, and run hybrid and virtual trials reliably.
Workflow friction
- Long start-up timelines across sites and vendors
- Inconsistent oversight of decentralised vendors
- Inspection findings on trial master file gaps
How the program helps
- Faster trial start-up with clear decentralised playbooks
- Stronger vendor oversight across CROs and home care
- Inspection-ready documentation built into daily work
Practice use cases
- dct design
- vendor oversight
- tmf completeness
Keep decentralised trial data clean and lockable
Data managers learn validation, query management, and database lock discipline for decentralised data sources.
Workflow friction
- Messy data from remote and wearable sources
- Late-breaking queries delaying database lock
- Validation gaps across decentralised tools
How the program helps
- Cleaner databases with fewer late queries
- Faster lock timelines through disciplined validation
- Reliable eSource and device data integration
Practice use cases
- data validation
- query management
- database lock
Detect and report safety signals from anywhere
Safety teams learn adverse event capture across remote channels and serious adverse event workflows that meet timelines.
Workflow friction
- Adverse events missed in remote channels
- Late or weak serious adverse event narratives
- Signal detection limited to site data
How the program helps
- On-time safety reporting from remote channels
- Stronger narratives that survive inspections
- Earlier signal detection from device data
Practice use cases
- ae capture
- sae narratives
- signal detection
Audit decentralised operations with confidence
QA teams learn audit preparation, trial master file review, and inspection readiness for decentralised models.
Workflow friction
- Audit findings on vendor oversight gaps
- Incomplete essential documents across tools
- Teams unprepared for mock inspections
How the program helps
- Audit findings closed with structured remediation
- Complete trial master files across vendors
- Calm, prepared teams during inspections
Practice use cases
- audit preparation
- tmf review
- mock inspections
Cohorts are grouped by role and trial experience so labs match the workflows each team owns.
Prerequisites: This program suits clinical operations, data management, pharmacovigilance, and QA staff who work with clinical trials. No prior decentralised trial experience is required, though familiarity with your organization's trial processes helps. Instructors adapt labs to your portfolio, vendors, and current decentralisation priorities.
Trial Associate to Decentralised Operations Lead
Start with trial foundations and DCT technology, advance through remote monitoring and safety reporting, and finish able to lead a decentralised trial operating plan.
One program that grows with clinical trial careers, from protocol basics to confident decentralised operations leadership.
Mixed cohort, or several teams at once?
We can tailor the training to different teams, roles, and experience levels within the same program.
Certificate of Training Completion.
On successful completion, employees receive an Edstellar course completion certificate, recognizing their commitment to ongoing learning and professional development. It validates the skills they have built and motivates them to keep growing and contribute to organizational success.
Earned, not attended. Awarded on completion of all hands-on labs and the capstone project.
Training Delivery Modes: Virtual, Onsite and Hybrid
Instructor-led delivery shaped to your trial operations calendar: live virtual for distributed teams, onsite for hands-on work, or hybrid for both.
Hybrid Training
A flexible mix of onsite sessions and live virtual labs, so clinical teams learn without missing trial milestones.
- Onsite sessions plus remote guided labs
- Calendar-friendly scheduling around milestones
- Live instructor guidance in every session
- Same curriculum and labs in all formats
Onsite Training
Delivered at your facility with instructors tailoring labs to your trial portfolio and vendor landscape.
- Tailored to your trials and decentralisation plans
- Direct observation of your team workflows
- Team-wide alignment in one room
- Hands-on labs with your scenarios
Live Virtual Training
Fully interactive live virtual sessions with guided labs in shared environments and small-group breakout work.
- Live instructor-led sessions, not recordings
- Guided labs in shared simulated environments
- Breakout rooms for functional groups
- Scheduling across time zones
Need a training format that works for your team?
Full days, half days across weeks, or split by module. Tell us the delivery window and we schedule the cohort around it.
Frequently Asked Questions
Share your team size, trial experience, and delivery preference and we will return a tailored quote within one business day.
Yes. A discovery call with a training advisor helps us map your trial portfolio and decentralisation goals to the curriculum.
Yes. Live virtual sessions run with guided labs in shared environments and breakout rooms for functional teams.
Yes. Onsite delivery is available at your facility, with instructors tailoring labs to your trial operations and tools.
The program runs 24 hours of instructor-led time, typically across 3 full days or six half-day sessions.
Question not answered here?
Put it in the request. A training specialist answers it directly, within one business day.
Where this Training Fits in Your Team's learning path.
Running trials follows GCP, because operations must meet ICH E6(R3) at every site. Once trials, including decentralised ones, run smoothly, your team manages the data they produce and then adds AI to improve recruitment and monitoring.
Why Choose Edstellar as Your Clinical Trial Operations and Decentralised Trials Training Provider
Edstellar delivers instructor-led clinical trial training built around your portfolio, your vendors, and outcomes you can measure.
EXPERT TRAINERS
YEARS DELIVERING
ORGANIZATIONS TRAINED
CERTIFIED
Tailored
Modules, labs, and the capstone are tailored to your trial portfolio, vendors, and decentralisation goals.
Proven Methodology
Training follows a proven assess, learn, practice, apply arc that turns trial findings into deployed fixes.
Practice-Based Learning
Six guided labs and a capstone have teams building eConsent journeys, monitoring plans, and safety narratives.
Expert Trainers
Sessions are led by clinical operations practitioners who run decentralised trials in regulated environments.
Global Scale
Consistent decentralised trial programs delivered across regions, time zones, and multi-site organizations.
Measurable Outcomes
Efficiency, quality, and safety metrics show exactly what each operations improvement delivered for your teams.
Design Decentralised Trial Operations With Connected Patient Safety and Oversight Processes
Edstellar connects trial foundations with hybrid delivery, remote engagement, data handling, and vendor oversight. Participants translate model protocols into operational workflows and practice safety documentation with simulated cases. The final operating plan is reviewed for process consistency, participant considerations, accountable handoffs, and the evidence supporting oversight decisions.
- Step 01
Consult
We assess trial-process familiarity and decentralisation priorities to identify gaps in hybrid visits, remote engagement, safety reporting, and vendor oversight.
- Step 02
Plan
We map protocol requirements before decentralised models, recruitment and remote monitoring, safety workflows, and vendor controls, then develop the complete operating plan.
- Step 03
Align
We align trial operations facilitation with clinical, data, pharmacovigilance, and QA roles, matching examples to the cohort's portfolio and vendor responsibilities.
- Step 04
Customize
We adapt model visit schedules, eConsent journeys, and safety case files to representative indications while using synthetic participant information throughout exercises.
- Step 05
Execute
Participants plan hybrid visits, script comprehension checks, and draft safety narratives, receiving feedback on operational handoffs, documentation, and vendor remediation choices.
- Step 06
Evaluate
We assess the trial operating plan for protocol alignment, coherent participant pathways, traceable safety responsibilities, and credible monitoring and vendor oversight arrangements.
Also from Edstellar
Talent assessments
Psychometric, behavioral, leadership and 360-degree assessment.
→Training needs analysis
Needs analysis, gap identification, and a training roadmap.
→L&D consulting
Learning strategy, content, technology and ROI measurement.
→OD consulting
Org design, succession planning and cultural change.
→Managed training services
Training outsourcing, vendor management, logistics and administration.
→Coaching solutions
Executive and manager coaching that keeps skills in use.
Start an RFP shaped to your needs.
Answer three quick questions about team size, scope, and how often you need the program run, then send the request from the last step. Everything you choose travels with it, so you only fill this in once.
How many team members need training?
Clinical Trial Operations & Decentralised Trials Training Packages & Pricing
Where L&D holds an annual budget, license packages price the whole year at once instead of raising a purchase order per workshop. Hours and licenses are pooled across teams, programs and locations, so unused capacity is not stranded in one department.
Starter
120
trainee licenses64 hours of group training
Tailored for SMBs
Growth
320
trainee licenses160 hours of group training
Ideal for growing SMBs
Enterprise
800
trainee licenses400 hours of group training
Designed for large corporations
Custom
Unlimited
trainee licensesDuration set by the rollout
Multi-region and multi-year
Training Packages & Pricing
Choose the training format that works for your team. Pricing is customized based on your requirements, cohort size, and delivery needs.
Request Clinical Trial Operations and Decentralised Trials Training for Your Team
Tell us about your team, trial portfolio, and timelines and we will design a decentralised trial program around your operations.