ClinSheets
ClinSheets is a Clinical PMO solution built on Smartsheet by DigitalRadius. It brings best-practice project management, automated reporting, and regulatory compliance to CROs, pharmaceutical companies, biotech firms, and medical device manufacturers.
Available on the Smartsheet Marketplace. Existing Smartsheet customers get started faster.
The challenge
Most clinical teams are managing complex, multi-site trials using a patchwork of Excel spreadsheets, email threads, shared drives, and generic project management tools — none of which were built for clinical research.
Trial timelines live in one spreadsheet, budgets in another, risks in a shared inbox. Nothing stays in sync.
Without proactive risk tracking, issues escalate before anyone notices. By the time they surface, timelines have slipped.
Sponsor updates require hours of data collation. Reports are out of date by the time they're shared.
Generic tools don't meet GxP, 21 CFR Part 11, or ALCOA+ requirements. Regulators are not forgiving of spreadsheet audit trails.
CROs, sponsors, and sites each maintain their own versions of the truth. Collaboration is friction.
Program-level dashboards don't exist. Leadership is always one meeting away from realising a trial is off track.
The solution
A single, purpose-built Smartsheet environment that gives every stakeholder — sponsors, CROs, project managers, sites — exactly what they need, when they need it. Built by clinical research professionals and Smartsheet experts who've lived the problem.
Features
A single source of truth for trial timelines, milestones, and budgets. Every stakeholder works from the same data, eliminating version-control chaos and cross-team misalignment.
Project schedules built by veterans with decades of combined experience in clinical research, project management, and Smartsheet solutions. Pre-configured for the real-world complexity of clinical trials — not generic projects.
Generate accurate, automated status reports for sponsors, leadership, and regulatory teams. No more Friday afternoon data gathering. Reports are always current and consistent across every trial.
Each stakeholder sees exactly what they need — and nothing more. Role-based Dynamic Views surface relevant risks and action items for sponsors, CROs, and project managers, with full accountability built in.
Proactive risk identification and escalation workflows that surface issues before they become delays. Teams can log, assign, and track resolution directly within the trial workspace.
Sponsor and leadership dashboards give program-level visibility across all active trials. Clean, modern web interface designed for the executive stakeholders who need the picture fast — not the detail.
Track and forecast trial budgets against actuals with automated variance alerts. Catch cost overruns before they become crises and maintain clean financial records for audit and review.
Designed for the full clinical trial ecosystem — sponsors, CROs, sites, and regulatory teams collaborate in one connected workspace. Clean, modern interface works for non-Smartsheet users too.
ClinSheets is designed and validated for GxP environments. DigitalRadius provides Computer System Validation (CSV) documentation, test protocols, and summary reports meeting 21 CFR Part 11 and ALCOA+ requirements.
First Smartsheet partner to offer GxP validationWho it's for
Manage multiple concurrent trials with consistent processes, centralized oversight, and client-ready reporting.
Gain full program visibility across your clinical pipeline, with executive dashboards built for sponsor accountability.
Purpose-built for the resource constraints and regulatory scrutiny of early and mid-stage biotech. Scales with you from Phase I through approval.
Manage clinical evidence generation with the same rigour as pharma — with a system built for the unique requirements of device trials.
Finally, a PMO toolset designed specifically for clinical operations — not adapted from a generic project management platform.
Real-time executive dashboards give sponsors and program leadership the visibility they need without wading through operational detail.
Compliance & validation
DigitalRadius is the first Smartsheet partner to offer a full Computer System Validation (CSV) package. ClinSheets deployments for regulated environments include complete GxP validation documentation — test scripts, execution records, and summary reports — delivered by our CSV specialists.
Our team has deep experience with 21 CFR Part 11, ALCOA+ principles, and the expectations of Quality, Clinical, and Regulatory teams at FDA-regulated organizations. We don't treat compliance as an afterthought — it's built into every ClinSheets deployment from day one.
CSV Documentation
Complete test scripts and protocols
50+ Biotech Deployments
Proven in regulated environments
21 CFR Part 11
Electronic records compliance
ALCOA+ Compliant
Data integrity principles met
Why Smartsheet
Real-time collaboration, automated workflows, role-based permissions, and audit trails — none of which Excel can reliably provide in a multi-user clinical environment.
ClinSheets delivers validated clinical PMO capability at a fraction of the cost of dedicated QMS, LIMS, DMS, or MES platforms — without the implementation timelines.
Many enterprise clients already have Smartsheet licenses. ClinSheets deploys into your existing environment — no new vendor procurement, no data migration to a separate system.
ClinSheets is developed and maintained by DigitalRadius — Smartsheet's 2023 New Partner of the Year and a Platinum-tier implementation and reseller partner. Our team includes former Smartsheet developers and clinical research professionals who have managed clinical programs at the world's leading pharmaceutical companies.
ClinSheets is listed on the official Smartsheet Marketplace and is deployed at 50+ biotech and pharmaceutical organizations globally.
Get started
Schedule a 30-minute discovery call with one of our ClinSheets specialists. We'll walk you through the solution, answer your compliance questions, and discuss what a deployment would look like for your organization.
