The CRM that treats a trial site as a first-class relationship, not a vendor row.
Clinical trial operations run on sponsor relationships, site activation, CRA monitoring cycles, protocol deviation tracking, and multi-stakeholder communication. Strkr ships a CRM shaped around trial work with sponsor pipelines, site coordination, CRA assignment, and AI drafting that respects clinical context.
Clinical trial operations do not fit a generic sales CRM. The sponsor relationship, the site network, the CRA assignment, the regulatory milestone, and the sponsor-reporting cadence are all first-class entities with their own cycles. The pain points below are what Strkr onboarding hears from CRO business development leaders, clinical operations teams, and sponsor-side trial managers.
Business development is multi-year
A sponsor relationship takes 18 to 36 months to warm up.
CRO business development runs on multi-year sponsor relationships that pre-date any specific trial award. The BD lead maintains relationships with sponsor VPs of clinical operations, program managers, and medical directors across 180 to 420 target sponsors. Strkr ships a Sponsor Relationship object with multi-year interaction history, award history, program alignment, and BD assignment that respects the long-cycle motion.
RFP response is a 60-page document
A clinical trial RFP response takes four weeks of writing.
A phase 3 trial RFP response typically runs 40 to 80 pages covering therapeutic experience, site network reach, operational capacity, regulatory posture, pricing, and timeline. The BD team spends four to eight weeks per RFP. Strkr ships an RFP response workflow with capability library, past-trial case studies, pricing templates, and AI drafting that cuts the first-draft timeline in half.
Site network is a coordination surface
A trial runs across 120 to 280 sites with varied activation status.
A pivotal trial coordinates across 120 to 280 sites with each site at a different activation stage (feasibility, contract negotiation, IRB submission, site initiation visit, enrollment active, enrollment complete, close-out). Strkr ships a Trial Site object with activation stage, assigned CRA, monitoring visit cadence, enrollment pacing, protocol deviation log, and sponsor reporting status.
CRA assignments and visits
A CRA covers 8 to 14 sites with 6 to 12-week visit cycles.
Clinical research associates each cover 8 to 14 sites with monitoring visits every 6 to 12 weeks. Visit scheduling, visit report completion, visit follow-up actions, and CRA utilization live across a mix of CTMS and project tracking tools. Strkr ships a CRA Assignment object with site coverage, visit calendar, visit report workflow, and utilization tracking.
Protocol deviation tracking
The deviation that becomes a GCP audit finding.
Protocol deviations occur across sites with varied severity (minor, major, critical). The sponsor expects deviation reporting on a defined cadence and the regulatory submission requires accurate deviation summary at trial close. Strkr ships a Protocol Deviation object with site, deviation type, severity, root cause, corrective action, and sponsor reporting status.
Sponsor reporting cadence
Monthly operational update plus quarterly executive deck.
Sponsors expect regular reporting (weekly enrollment pacing, monthly operational detail, quarterly executive summary). Each sponsor wants a slightly different format. The trial manager spends 11 to 24 hours per month on sponsor reporting. Strkr ships sponsor reporting templates with AI-drafted narrative grounded in the actual trial data.
The clinical trial operations schema
Objects shaped like trial work.
The default CRM schema does not reflect clinical trial operations. Strkr ships a tunable schema with Sponsor, Trial, Trial Site, CRA Assignment, Protocol Deviation, Site Contact, and Sponsor Deliverable as first-class objects.
Sponsor object
Pharma, biotech, device, government.
A Sponsor in Strkr carries sponsor type (large pharma, mid pharma, biotech, device, government), therapeutic area focus, prior-engagement history, BD lead assignment, program alignment, and overall relationship tier. The schema distinguishes sponsors by scale and operational posture, which matters for proposal pricing and operational approach.
Trial object
Phase, indication, protocol, award.
A Trial ties to the Sponsor and captures phase (1, 2, 3, 4), therapeutic indication, protocol number, award value, operational timeline, enrollment target, site target, country footprint, lead investigator, and lead project manager. The schema drives the operational workflow for the duration of the trial.
Trial site object
Activation, enrollment, CRA, deviations.
A Trial Site captures site identity (institution, principal investigator, site coordinator), activation stage, assigned CRA, monitoring visit cadence, enrollment pacing against target, protocol deviation count, and sponsor reporting status. The site feeds the enrollment reporting and operational cockpit.
CRA assignment object
Site coverage, visit cadence, workload.
A CRA Assignment captures CRA identity, assigned sites, monitoring visit cadence, planned visit calendar, visit report status, utilization against target, and travel schedule. The schema drives the CRA workload management and sponsor reporting on monitoring compliance.
Protocol deviation object
Site, type, severity, root cause.
A Protocol Deviation captures the site reference, deviation type (consent, enrollment, dosing, assessment, data entry), severity (minor, major, critical), root cause, corrective action, CAPA status, and sponsor reporting status. The schema feeds the trial-close deviation summary and the regulatory submission.
Site contact object
PI, SC, pharmacist, regulatory, finance.
A Site Contact captures the role at the site (principal investigator, site coordinator, research pharmacist, regulatory, finance), authorized communication scope, preferred communication channel, and last-touch cadence. The schema supports the multi-stakeholder communication pattern that trial operations requires.
Sponsor deliverable object
Reporting cadence, format, status.
A Sponsor Deliverable captures the deliverable type (weekly enrollment update, monthly operational report, quarterly executive deck, regulatory milestone update, ad-hoc deep dive), cadence, format template, assigned owner, and last-delivery status. The schema drives the sponsor-reporting workflow.
How Strkr AI drafts for trial operations
The AI jobs that fit CRO and sponsor work.
Clinical trial communication is technical, regulatory-aware, and audience-tuned. Strkr AI drafts in the voice the trial manager would use with retrieval scope strictly scoped to the trial record and the site network.
RFP response draft
Therapeutic experience and site reach.
Strkr AI drafts the RFP response sections (therapeutic experience, site network reach, operational capacity, regulatory posture, pricing rationale) from the CRO capability library, the past-trial case studies, and the specific RFP requirements. The BD lead tunes the strategic framing. The RFP that previously took four to eight weeks drops to two to four weeks of effective work.
Site activation email
The outreach to the site coordinator.
Strkr AI drafts the site activation outreach with the trial scope, site expectations, next-step detail, and timeline. The site activation specialist approves and sends. Site activation cycle time drops because the outreach lands specific instead of generic.
CRA visit summary
The post-monitoring-visit note.
After a monitoring visit Strkr AI drafts the visit summary with the site observations, protocol compliance assessment, deviation discoveries, and action items. The CRA reviews, tunes, and files. The visit summary feeds the monitoring report workflow and the sponsor reporting.
Sponsor operational report
The monthly operational narrative.
Strkr AI drafts the monthly sponsor operational report with enrollment pacing summary, site activation status, protocol deviation summary, CRA monitoring compliance, and operational risk assessment. The trial manager tunes the strategic framing. The sponsor sees a consistent, data-grounded report every month.
Protocol deviation CAPA
The root-cause and corrective-action draft.
For protocol deviations requiring CAPA Strkr AI drafts the root-cause analysis and corrective-action plan grounded in the deviation detail and the site history. The quality assurance lead reviews and files. CAPA quality improves because the draft lands specific rather than generic.
Investigator meeting agenda
The agenda for the trial kickoff.
For investigator meetings Strkr AI drafts the agenda with the trial overview, protocol detail, operational workflow, data entry expectations, safety reporting, and site-specific Q&A. The trial manager tunes the agenda before the meeting. The agenda lands at a consistent quality bar across trials.
Trial-close summary
The final narrative for sponsor.
At trial close Strkr AI drafts the trial close summary with enrollment achievement, site performance analysis, protocol deviation summary, operational observations, and lessons-learned narrative. The trial manager tunes the strategic framing. The sponsor sees a comprehensive close report grounded in the actual trial data.
The trial operations cockpit
The real-time view that replaces the Excel sheet.
Clinical trial managers run on daily situational awareness. Strkr ships a trial operations cockpit that pulls site activation, enrollment pacing, CRA monitoring compliance, protocol deviations, and sponsor deliverables onto a single view.
Site activation funnel
Sites in each activation stage.
The site activation section shows every site colored by stage (feasibility, contract, IRB, site initiation, enrollment active, enrollment complete, close-out). The trial manager sees which 11 sites are stuck in IRB and need an intervention this quarter.
Enrollment pacing
Site-level and global pacing versus target.
The enrollment section shows site-level enrollment pacing with the global cumulative pacing against target. Sites behind pace flag for an intervention. The trial manager sees the top under-performing sites and can deploy support (additional recruitment resources, protocol amendment, site replacement).
CRA monitoring compliance
Visits on schedule versus overdue.
The CRA monitoring section shows every CRA with their site coverage, visit calendar, overdue visits, and visit report completion rate. The clinical operations lead sees which CRAs are behind on monitoring and can rebalance workload.
Protocol deviations
Deviations by severity and site.
The deviation section shows active deviations by severity with site attribution and CAPA status. Critical deviations surface prominently with the sponsor reporting status. The quality assurance lead works the queue.
Sponsor deliverables
Reports due this week and overdue.
The sponsor deliverable section shows deliverables due this week, in flight, and overdue. The trial manager works the queue each week to keep sponsor reporting on cadence. AI-drafted narrative reduces the drafting cost per report.
Site communication activity
Touches to site contacts in the past 30 days.
The site communication section shows outbound touches by site contact in the past 30 days. Sites with low touch frequency flag for the project manager. Site communication cadence lifts because the gap visibility is clear.
Head-to-head
Strkr vs CTMS plus Veeva Vault or a generic sales CRM for clinical operations.
The comparison below is Strkr's clinical trial posture versus a typical CTMS or life-sciences CRM applied to a mid-size trial portfolio.
Feature
Strkr
CTMS or life-sciences CRM typical
Sponsor relationship object
Multi-year interaction history.
Not a first-class object.
RFP response workflow
Capability library plus AI drafting.
Manual Word document.
Trial site activation funnel
Live view with stage distribution.
Spreadsheet.
CRA utilization tracking
Visit calendar and workload.
Project tracking tool.
Protocol deviation with CAPA
Root cause and corrective action.
EDC note.
Sponsor reporting cadence
Templated with AI narrative.
Manual drafting each cycle.
HIPAA with BAA
Available on request.
Enterprise tier typical.
21 CFR Part 11 posture
Audit log plus role-based access.
Validated for specific use.
Pricing
Flat per seat.
Per-trial or per-site fee common.
How teams use Strkr
Four clinical trial playbooks.
The playbooks below are patterns Strkr onboarding sees across CRO and clinical trial deployments.
Pattern A
The 42-person mid-size CRO business development team.
A mid-size CRO with 42 business development team members pursued 180 to 240 RFPs per year with a 32 percent win rate. The BD leaders spent 11 hours per week on sponsor relationship management across 420 target sponsors. Strkr onboarding configured the Sponsor Relationship object with multi-year interaction history. BD coverage improved and the win rate ticked up 4 points as the RFP response quality improved with the capability library and AI drafting.
Pattern B
The 120-site phase 3 trial.
A sponsor-side clinical operations team ran a 120-site phase 3 trial with 24 CRAs on 8-week monitoring cycles. The team used Medidata CTMS as the EDC and operational system of record. Strkr onboarding configured the Trial Site object with CTMS integration through the webhook spec. The trial operations cockpit replaced a 60-tab Excel sheet. Enrollment pacing improved 18 percent and protocol deviation CAPA completion improved to 100 percent within target timelines.
Pattern C
The 24-sponsor CRO portfolio.
A mid-size CRO running 24 active sponsor engagements across 68 trials needed portfolio-level visibility for the chief operating officer. Strkr onboarding configured the sponsor and trial objects with portfolio reporting that rolled up to the COO. Portfolio-level operational risk visibility improved. The COO ran the weekly portfolio review on the Strkr cockpit instead of a mid-month manual roll-up.
Pattern D
The oncology-specialist CRO.
An oncology-specialist CRO with 180 staff focused on oncology trials for mid-size biotech sponsors. The team needed specialized oncology-specific protocol deviation taxonomy and the AI drafting had to respect oncology clinical context. Strkr onboarding configured the Protocol Deviation object with oncology-specific taxonomy and the AI retrieval scope with oncology-specific context. The specialized posture gave the CRO a competitive edge in oncology RFPs against generalist CROs.
Run clinical trial operations on a CRM shaped for CRO and sponsor work.
Book a 30 minute call. We will walk through the trial operations schema, the site coordination workflow, and the sponsor reporting cadence with your actual trial portfolio.
Does Strkr integrate with Medidata, Oracle Clinical One, Veeva Vault, or Castor EDC?
Strkr integrates with every major CTMS, EDC, and eTMF through its REST and GraphQL API, outbound webhooks with HMAC signing, and the published OpenAPI spec. The typical setup pulls site activation events, enrollment events, and protocol deviation events from the CTMS or EDC on a webhook-driven cadence. For Medidata CTMS, Oracle Clinical One, Veeva Vault CTMS and eTMF, Castor EDC, and Clario the integration lands in two to four engineering sprints. Strkr becomes the operational CRM layer while the CTMS stays as the clinical system of record.
How does Strkr handle 21 CFR Part 11 and the regulated clinical data posture?
Strkr's audit log captures every record read, record write, and AI call with timestamp, user, and immutable retention tunable per tenant to the FDA requirement. The role model supports granular permission scoping consistent with Part 11 access controls. For specific validated-system use cases (where Strkr serves as a direct source for regulatory submission) a dedicated validation engagement runs with the quality assurance team and may require additional documentation. The audit log and access control posture meets the baseline Part 11 requirements out of the box.
Can Strkr handle a CRO running trials across multiple therapeutic areas?
Yes. The admin configures therapeutic areas (oncology, cardiology, neurology, immunology, rare disease, infectious disease, metabolic) with therapeutic-area-specific protocol deviation taxonomy, sponsor relationship patterns, and site network overlays. A trial team working in a therapeutic area sees the therapeutic-area context with the general operational workflow consistent across therapeutic areas. Portfolio reporting rolls up across therapeutic areas for the operations leadership.
What does Strkr cost compared to Medidata CTMS, Veeva Vault, or custom build?
Strkr prices flat per seat at $29 Starter, $59 Pro, and $119 Scale per user per month with a 14-day trial. For a 120-person CRO on Scale the monthly spend runs $14,280 for seats plus $49 for AI Enhancement. Medidata CTMS typically runs per-site or per-trial pricing with mid-six-figure to seven-figure annual contracts for mid-size CROs. Veeva Vault runs similar. Custom builds on top of Salesforce Health Cloud run higher still. Strkr sits dramatically lower on cost while adding the AI drafting and the modern API posture.
How does Strkr handle multi-stakeholder communication at a site (PI, SC, pharmacist, regulatory)?
The Site Contact object captures each role at the site with authorized communication scope, preferred communication channel, and last-touch cadence. The communication workflow routes outbound communication to the right role based on the message type (regulatory update goes to the regulatory contact, operational update goes to the site coordinator, financial update goes to the finance contact). The multi-stakeholder pattern reduces the back-and-forth that occurs when the wrong contact gets the wrong message.
Can we run the RFP response workflow in Strkr with multi-author collaboration?
Yes. The RFP response workflow supports multi-author collaboration with capability library (reusable sections for therapeutic experience, site network, operational capacity, regulatory posture), past-trial case studies, pricing templates, and AI drafting. Multiple authors can edit sections concurrently with revision tracking. The BD lead assembles the final response. The workflow typically cuts the first-draft timeline in half while improving quality through consistent capability-library usage.
What is the full compliance posture for a clinical trial operation?
Strkr is HIPAA compliant with BAA on request, 21 CFR Part 11 baseline (audit log plus role-based access) with validated-system engagements available on request, GDPR and CCPA compliant today, and SOC 2 Type II is in progress with a target of 2026-Q4. Integration tokens live in AWS KMS, platform credentials live in AWS Secrets Manager. The audit log captures every record read, record write, and AI call with 90-day default retention tunable per tenant to the FDA, EMA, PMDA, and other agency retention requirements. SSO (SAML and OIDC) is live on Scale tier through Clerk, MFA with TOTP plus text-based verification is live across all tiers, and Verified Domains are live on Scale tier.
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