The TrialTrack Blog
Notes from the trial floor
Practical writing on running multi-site clinical trials — operations, compliance, and how we build TrialTrack.
Affordable CTMS for Small Biotech: Needs and Costs
For a small biotech the question isn’t “which CTMS is cheapest?” but “what do we actually need?” Affordable needn’t mean non-compliant — here’s how to tell.
Veeva Vault Alternatives: Which Vault Are You Replacing?
“Veeva Vault” isn’t one product, so “find an alternative” is meaningless until you say which. Identify the bottleneck you’re replacing before you shortlist.
CTMS Pricing: The Four Models and Hidden Cost Drivers
“How much does a CTMS cost?” has no single answer, and the $4K–$1M+ ranges are useless. The four pricing models, and the hidden drivers behind budget surprises.
Clinical Trial Management: A Lean Operating Model Under GCP
Clinical trial management is the discipline of running a trial well under GCP — the practice, not the software. A lean model built on quality by design.
Clinical Trial Workflow: The Whole Trial as One Flow Chart
A clinical trial is best read as one end-to-end flow chart: four stages, with the handoffs and decision gates between them — and where trials actually stall.
Electronic Data Capture (EDC): One Layer in the Stack
Electronic data capture records trial data into eCRFs — one layer in the eClinical stack, not the whole thing. How the entry-check-query-lock loop works.
Pharma Project Management: A Map of the Drug Value Chain
Pharma project management is a relay across the whole drug value chain, not task-tracking in one stage. A stage-by-stage map of where the work actually sits.
Project Management in Clinical Research: The Playbook
The how-to half of clinical project management: how a lean team stands up PM practice across the trial lifecycle, with the artifacts each phase produces.
GxP Compliance: The Acronyms and the Three Shared Controls
GxP is a family of “Good x Practice” disciplines, not one certificate you pass. The acronyms decoded, and the three software controls they all converge on.
Computer System Validation Testing: Risk-Based Execution
CSV testing isn’t “run every prewritten IQ/OQ/PQ script.” A risk-based approach to what to test, how rigorously, and where vendor evidence replaces scripting.
Computer System Validation Protocol: The V-Model Paper Trail
A CSV package is a connected chain of documents following the V-model, not one “protocol.” The full deliverable set, and the matrix that ties it together.
FDA Guidance on Computer System Validation: CSV to CSA
Computer system validation is governed by a connected arc of FDA documents, not one — reading the shift from exhaustive CSV to risk-based assurance (CSA).
21 CFR Part 11 for Excel Spreadsheets: The Missing Controls
A native spreadsheet isn’t Part 11 compliant, for structural reasons. Why Track Changes isn’t an audit trail, and the controls a spreadsheet can’t provide.
21 CFR Part 11 Checklist: A Section-Referenced Self-Audit
A section-by-section Part 11 self-audit with exact subsection references, a pass/partial/fail column, and break-out checklists for the controls teams miss.
21 CFR Part 11 Compliant Software: Vendor Claim vs. Reality
“Part 11 compliant software” is a vendor claim, not a switch you can buy. What vendors actually ship, and the configuration, validation, and SOPs you own.
ICH E6(R3): What Actually Changed, and What to Do About It
E6(R3) is a structural rewrite of GCP, not a touch-up. What changed — risk-based quality management, essential records, monitoring — and what to do next.
Clinical Data Management: The Lifecycle, Step by Step
Clinical data management turns messy trial data into a clean, locked, defensible dataset — the lifecycle phase by phase, and the control proving each step.
Clinical Project Management: A Discipline, Not a Job Title
Clinical project management is its own discipline, not generic PM with a compliance bullet bolted on — why coordination, not the Gantt chart, is the real job.
Computer System Validation: A Plain-Language Guide
Computer system validation is documented evidence that a system does what it’s specified to do — a risk-and-evidence discipline, not a paperwork ritual.
ICH GCP Guidelines: The 11 Principles as an Operating Model
ICH GCP isn’t a checklist to pass an inspection — it’s an operating model. The 11 principles of E6(R3), read as how to think about a trial, not boxes to tick.
Audit Trail Example: An Annotated Record, Field by Field
An audit trail answers who, what, when, and why for every change. A real annotated example, field by field, and what separates it from an ordinary log.
ALCOA Principles: An Accountability Map for Data Integrity
ALCOA isn’t a glossary to memorize — it’s an accountability map. For each attribute, who owns it on a trial and the data-integrity failure it prevents.
21 CFR Part 11: A Conditional Rule, Not a Checklist
Part 11 is conditional: it bites only once a predicate rule applies. What’s actually in scope, and why “compliant software” is a claim, not a switch.
Clinical Trial Software: Mapping the eClinical Stack
“Clinical trial software” isn’t one product — it’s a stack of layers (CTMS, EDC, eTMF, IRT) that each do a different job. A buyer’s map of the eClinical stack.
Clinical Trial Management System (CTMS): A Buyer’s Guide
A CTMS is the operational command center of a trial — but not every team needs one. What it does, who needs one, and how to choose without overbuying.