Shawnee Biodata Schedule a Strategy Session

Big Pharma data rigor at biotech speed.

Focused solely on emerging biopharma R&D data

Govern the data. Streamline the flow. Validate by design. Approval-ready data Therapies to patients sooner

Every trial depends on secure, accurate, auditable data. We help emerging biopharma govern it, streamline the workflows around it, and validate the GxP systems that hold it, so you start faster, stay inspection-ready, and reach patients sooner.

Schedule a Strategy Session Explore Capabilities
25+
Years of GxP Digital & Structured Data Leadership
100+
Enterprise implementations
33%+
Improved implementation and adoption through an adaptive SDLC approach
33%+
Faster CSA validation times
Capabilities

GxP Implementation and Adoption Services

Practical, senior-led support across the quality, regulatory, and technology functions that keep R&D moving.

01

GxP Project Management and SDLC Leadership

Senior-led project management across the full solution delivery lifecycle, from initiation through go-live and adoption. Each phase produces defined project deliverables alongside risk-based CSA validation evidence, so planning, requirements, build, testing, and cutover stay traceable and audit-ready. Steering committee governance, RAID and change control, budget tracking, and KPI reporting run across every phase, keeping programs on schedule, on budget, and inspection-ready.

GxP SDLC project management deliverablesSix SDLC phases: initiate, plan, design, build, validate, and deploy and adopt. Each phase lists project management deliverables and CSA validation deliverables, with governance running across all phases.1 · InitiatePM DELIVERABLES• Project charter• Business case• Stakeholders & RACI• Current-state reviewCSA VALIDATION• GxP assessment• System risk rating2 · PlanPM DELIVERABLES• Schedule & milestones• Budget & resources• Communication plan• RAID logCSA VALIDATION• CSA validation plan• Supplier assessment3 · DesignPM DELIVERABLES• User requirements• Process maps• Migration strategy• Design sign-offCSA VALIDATION• Risk assessment• Configuration spec4 · BuildPM DELIVERABLES• Build plan• Configuration tracking• Integration plan• Migration dry runsCSA VALIDATION• Test strategy• Traceability matrix5 · ValidatePM DELIVERABLES• UAT plan & execution• Defect triage• Training materials• Go / no-go criteriaCSA VALIDATION• Assurance evidence• Validation summary6 · Deploy & adoptPM DELIVERABLES• Cutover plan• Go-live & hypercare• Adoption metrics• Lessons learnedCSA VALIDATION• Release to operations• Periodic review planGovernance across all phases: steering committee · status reporting · RAID and change control · budget tracking · KPIsSDLC phaseProject management deliverablesCSA validation deliverables
GxP SDLC: project management and CSA validation deliverables by phase.
02

Quality Management System (QMS)

Strategy, implementation, and user adoption for QMS platforms and the quality processes they run: deviations, investigations, CAPA, change control, complaints, audits, document control, and training. We connect quality events to document and training updates, link change control to regulatory impact assessment, bring suppliers and CMOs into shared processes, and validate with a risk-based CSA approach, so quality operations stay inspection-ready.

Quality Management System process flowDeviations, lab results, and complaints enter event intake, then move through investigation, CAPA, change control, and effectiveness check. The QMS core holds quality events, CAPAs, changes, audits, and the risk register, and exchanges data with RIM, ERP/MES, suppliers, and reporting. Change control triggers document updates, which trigger training that feeds the effectiveness check. Operations / labs Deviations, OOS / OOT Complaints Customers, safety / PV Event intake Triage, classify Investigation Root cause, risk CAPA Corrective, preventive Change control Impact assessment Effectiveness check Verify and close QMS Core Quality events CAPA and changes Audits Quality risk register Document control SOPs, specs, versions Training Role-based assignments RIM Variation assessment ERP / MES Batch holds, release Suppliers / CMOs Shared events, audits Reporting Trends, KPIsQuality event lifecycleQMS data and recordsConnected systems and partners
QMS process flow: quality event lifecycle, QMS records, and connected systems.
03

Regulatory Information Management (RIM)

Strategy, implementation, and adoption for RIM platforms and the regulatory business processes around them. We act as business system and product owner, aligning Regulatory, process owners, Quality, IT, and CSV through a cross-functional governance model and a clear RACI. We strengthen regulatory data governance and integrity, enable CDISC-to-eCTD data reuse with end-to-end traceability, and validate with a risk-based CSA approach, so your regulatory operations stay inspection-ready and prepared for emerging health authority data requirements.

Regulatory Information Management data flowSafety and clinical content feeds authoring, document management, publishing, validation, and gateway dispatch to health authorities. The RIM core holds registrations, commitments, HA correspondence, and submission plans, exchanges data with QMS, IDMP/SPOR, labeling, and ERP, and is updated from the sequence archive. Safety / PV PSUR / PBRER Clinical CTMS / eTMF Authoring Templates, SCA Doc Management Review, approve Publishing eCTD build Validation HA rule checks Gateway ESG, CESP, CTIS RIM Core Registrations Commitments HA correspondence Submission plans Archive Sequence record HA (FDA, EMA) Acknowledgments QMS Change control IDMP / SPOR Product data Labeling CCDS to local ERP / SAP Market releaseSubmission pipelineRIM data and recordsConnected systems / HA
RIM data flow: submission pipeline, RIM records, and connected systems.
04

Validated Development Data Cloud

A CDISC-based data foundation, built in SQL, that captures clinical and nonclinical data once, governs it centrally, and repurposes it into submission-ready content. SDTM is the single source of truth: analysis datasets, results, and approved content blocks all trace back to it, and the hub shares data directly with RIM, product master data (IDMP/SPOR), labeling, and QMS change control. A correction made once reaches every output, so submissions are assembled, not rebuilt.

CDISC-to-eCTD development data architectureProtocol, EDC, external, and nonclinical data are captured into CDISC SDTM, ADaM, ARS results, and SEND, with SDTM as the single source of truth. That data drives reusable structured content, results, reviewer guides, and a component library, which populate eCTD modules M5, M4, M2.5 and M2.7, and M1 labeling. A standards and metadata hub governs the flow, content is reused beyond eCTD, and traceability runs from every dossier claim back to the protocol.Standards and metadata hub: CDISC controlled terminology · metadata repository · biomedical concepts · define.xml templates · dataset specs1 · CAPTUREProtocol and SAPICH M11 · CDISC USDMEDCCDASH-aligned CRFsExternal dataLabs, PK, eCOA, devicesNonclinicalToxicology studies2 · CDISC DATASDTMSingle source of truthADaMAnalysis-ready datasetsARS resultsTLFs stored as dataSENDNonclinical tabulation3 · REUSABLE CONTENTStructured contentObjectives, endpoints, methodsResults and key messagesLinked to ARS outputsReviewer's guidesdefine.xml, cSDRG, ADRGComponent libraryApproved once, reused4 · ECTD DOSSIERM5 clinicalCSRs, SDTM and ADaM datasetsM4 nonclinicalReports, SEND datasetsM2.5 / M2.7Clinical overview, SCS, SCEM1 labelingClinical studies sectionReuse beyond eCTD: ClinicalTrials.gov / EU CTIS results · Investigator's Brochure · DSUR · publications · HA responses · IDMPTraceability and governance: dossier claim → TLF → ADaM → SDTM → CRF → protocol · audit trail · access and change control
CDISC-to-eCTD data architecture: SDTM as the single source of truth, reused across the dossier and beyond.

How it's built

  • 01
    Store the rulesCDISC standards and approved terms are loaded as reference tables, so every record is checked automatically and standards stay under change control.
  • 02
    Describe the studyObjectives, endpoints, arms, and visit schedule are stored as data, so everything collected links back to the protocol.
  • 03
    Hold the data onceOne table per SDTM domain, one row per observation. EDC, lab, device, and SEND data land here once and are never copied.
  • 04
    Derive the analysisADaM datasets are built from SDTM by versioned rules, and results are stored as numbers, not PDFs.
  • 05
    Assemble the contentApproved text blocks link to result rows, so documents pull current numbers instead of retyping them.
  • 06
    Validate and auditAudit trail, access control, and version history on every table, validated with a risk-based CSA approach.

Connected to regulatory systems

  • RIM
    RIMSubmission plans and tracking, with every submitted item linked to its source data.
  • IDMP
    IDMP / SPORProduct names, strengths, forms, and sites stored once and identical in every filing.
  • LBL
    LabelingThe label's clinical studies section pulls its numbers from stored results.
  • QMS
    QMS change controlLinked records turn regulatory impact assessment into a lookup.

Repurposed into submission-ready eCTD content

  • M5
    M5 clinical · M4 nonclinicalDatasets exported in FDA formats; define.xml and reviewer's guides generated from metadata.
  • M2
    M2.5 / M2.7 summariesNarrative assembled from approved components, numbers pulled from stored results.
  • M1
    CSR · M1 labelingOne source for the CSR, summaries, and label, so they can't contradict each other.
  • LC
    Lifecycle updatesA changed number flags every affected section; the next sequence replaces exactly those.

Reuse beyond eCTD: Investigator's Brochure · DSUR · ClinicalTrials.gov / EU CTIS results · publications · health authority responses

What it means for the business

  • ✓
    Faster filingsEvery update, new indication, and new country reuses approved content.
  • ✓
    Consistent across health authoritiesFDA, EMA, and PMDA receive the same verified data.
  • ✓
    Inspection-ready traceabilityAny dossier statement traces back to the protocol in seconds.
  • ✓
    Ready for structured submissionsBuilt for IDMP, structured product quality, and eCTD 4.0.

Capture data once, govern it centrally, and repurpose it into submission-ready content for every filing, every market, and every update.

05

Interim R&D IT Leadership

Experienced, embedded R&D IT leadership during leadership gaps, reorganizations, or rapid growth. We stabilize operations in the first weeks, assess the application, data, and GxP compliance landscape, then put governance, a prioritized roadmap, and vendor and CRO oversight in place to get in-flight programs back on track. Every engagement ends with a clean handover: a documented operating model, knowledge transfer, and support hiring and onboarding your permanent leader.

Interim R&D IT leadership engagement modelFour phases: stabilize in weeks one to four, assess in weeks four to eight, govern and deliver in months two to six, then transition to a permanent leader. Each phase lists leadership deliverables and outcomes. Functions supported include research, clinical, regulatory, quality, data and AI governance, and IT security.1 · StabilizeWeeks 1–4LEADERSHIP DELIVERABLES• Stakeholder and team map• Critical risk and issue log• Vendor and contract inventory• Quick-win prioritiesOUTCOMES• Operations continue• Immediate risks contained2 · AssessWeeks 4–8LEADERSHIP DELIVERABLES• Application and data landscape• GxP compliance gap review• Budget and resource review• Team capability reviewOUTCOMES• Clear current state• Prioritized gap list3 · Govern and deliverMonths 2–6LEADERSHIP DELIVERABLES• IT governance and intake model• Roadmap and portfolio plan• Vendor and CRO oversight• In-flight program recoveryOUTCOMES• Programs back on track• Inspection-ready controls4 · TransitionHandoverLEADERSHIP DELIVERABLES• Operating model and RACI• Permanent leader hiring support• Knowledge transfer• First 90-day plan for successorOUTCOMES• Successor set up to succeed• Momentum sustainedR&D functions supported: Research · Clinical · Regulatory · Quality · data and AI governance · IT securityEngagement phaseLeadership deliverablesOutcomes
Interim leadership engagement: from stabilization to handover.
Method

Our Approach

A disciplined, six-stage engagement model built for GxP environments and tuned for biotech speed.

01

Assess

Understand current state, risk, and readiness.

02

Design

Define the target operating model and architecture.

03

Plan

Sequence the roadmap and align stakeholders.

04

Deliver

Implement with GxP-grade rigor and speed.

05

Validate

Confirm compliance, quality, and inspection readiness.

06

Optimize

Continuously improve process and performance.

Why Shawnee Biodata

Why emerging biopharma works with us

Small teams can't afford a slow, generic, or junior-staffed rollout. We're built for exactly that gap.

01

Senior-led, start to finish

A 25-year practitioner runs your program from kickoff to go-live. No junior handoffs, no bait-and-switch staffing.

02

Compliant by design

Validation, data integrity, and inspection readiness are built into every decision, not bolted on before an audit.

03

Vendor‑independent

Recommendations based on your stage, budget, and pipeline, not on a platform we're paid to sell.

04

Right-sized for biotech

Fractional, focused support that moves at your pace and scales as programs advance toward approval.

Insights

Perspectives on GxP, quality, and digital R&D

Technology

AI in GxP

Compliance

FDA Data Integrity

Quality

Computer Software Assurance

Digital

Digital Quality Transformation

Strategy

Emerging Biotech

Compliance

Inspection Readiness

Engagement Models

Work with us the way that fits

Strategic Advisory

Executive-level guidance to shape quality, regulatory, and digital strategy before you commit resources.

Project Delivery

Hands-on implementation and SDLC leadership to see initiatives through to validated go-live.

Interim Leadership

Embedded R&D IT leadership to keep programs moving during transitions or growth.

Schedule a Strategy Session

Let's discuss your challenges and explore how Shawnee Biodata can help strengthen data integrity, ensure compliance, and accelerate your R&D success.

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