KaMma Clinical Research — Precision CRO Delivery
Sponsor-ready delivery • Site-friendly execution

Clinical research delivery that is precise, compliant, and human.

KaMma Clinical Research partners with sponsors and sites to move studies forward with clarity—strong operations, clean data, and reliable timelines across regions.

Studies supported
120+
Phase I–IV programs with audit-ready documentation.
Regions
Global
Flexible resourcing across time zones and languages.
Start-up speed
Fast
Clear critical path, predictable handoffs, fewer surprises.
Program Health
On track
Sites activated
18
+3 wk
Data queries
Low
stable
Monitoring cadence
Risk-based with clear triggers
Targeted SDV, centralized review, and rapid feedback loops—built for quality and speed.
Audit-ready
SOP-aligned deliverables from day one
See approach
Reference-inspired layout: clean bands, strong typography, and operational clarity—designed to feel enterprise-grade without losing warmth.
Trusted delivery for sponsors & sites
Built to align with enterprise expectations
Sponsor Partner
Academic Network
Site Alliance
Registry Program
eCOA Vendor

Services designed for sponsor confidence

Modular support across the full study lifecycle—delivered with consistent SOPs, clear ownership, and transparent reporting.

Clinical Operations

  • Site engagement with clear expectations
  • Monitoring plans aligned to risk
  • Faster issue resolution via escalation paths

Data Management

  • CDISC-minded standards and QC
  • Query strategy to reduce site burden
  • Clean, traceable datasets for lock

Biostatistics

  • SAPs with defensible assumptions
  • TFLs designed for clarity and review
  • Rapid interim analytics when needed

Medical Writing

  • Protocols, IBs, CSRs, and narratives
  • Consistent QC and version control
  • Clear authoring timelines aligned to milestones

Regulatory

  • Submission-ready packages and tracking
  • Country-by-country start-up support
  • Documentation aligned to inspection needs

Pharmacovigilance

  • Case intake, triage, and follow-up
  • Safety reporting with clear timelines
  • Signal support & reconciliation workflows

End-to-end delivery, mapped to decisions

A clear, repeatable pathway that reduces friction between functions—so teams spend less time translating and more time delivering.

1
Discover
Scope, risk, and success criteria
Deliverables: draft critical path, data strategy, monitoring approach, and a practical resourcing model aligned to your milestones.
2
Start-up
Sites, vendors, documents, systems
Deliverables: country/site activation plan, TMF structure, training completion tracking, and readiness checks for first patient in.
3
Execute
Recruitment, monitoring, data quality
Deliverables: issue management cadence, metrics dashboards, query strategy, RBM triggers, and sponsor-ready communications.
4
Close-out
Lock, CSR, readiness, learnings
Deliverables: clean TMF, database lock support, final listings, submission artifacts, and a lessons-learned package for next study.
Operations view
Timeline & deliverables dashboard
Milestone control
Critical path visibility with owners and dates.
Issue triage
Centralized review, fast escalation, documented closure.
Key deliverables: Study plan RBM strategy TMF index DB lock checklist
Screens are illustrative; KaMma supports your preferred stack (EDC, CTMS, eTMF, eCOA) and reporting formats.
Operational cadence
Weekly sponsor sync + proactive risk register updates
Ask about reporting

Therapeutic experience that’s easy to navigate

Filter by area to see a concise view of what KaMma brings: operational strengths, data considerations, and site collaboration patterns.

Coverage
Multi-region coordination

KaMma supports global operations through standardized playbooks, local regulatory awareness, and proactive site communications.

Therapeutic Area
Oncology

Complex eligibility, safety reporting discipline, and tight coordination across sites.

RBM-ready Safety workflows Data review
Therapeutic Area
CNS

Endpoint consistency, rater training logistics, and patient-centric visit planning.

Rater training eCOA Site support
Therapeutic Area
Cardio-metabolic

High visit volume programs with disciplined data cleaning and recruitment pacing.

Recruitment pacing Lab flows TFL clarity
Therapeutic Area
Infectious Disease

Fast timelines, operational readiness, and strict protocol adherence for safety.

Rapid start-up Safety focus Central review
Therapeutic Area
Rare Disease

Specialized sites, travel logistics, and careful data interpretation for small cohorts.

Site networks Patient support Protocol clarity
Therapeutic Area
Immunology & Inflammation

Visit windows, lab coordination, and consistent AE documentation across sites.

Consistency Lab workflows Oversight
Don’t see your area?
We scope based on protocol complexity and operational needs.
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Quality you can audit. Technology you can integrate.

KaMma operates with SOP-driven delivery, QA oversight, and risk-based monitoring. We integrate into your toolchain rather than forcing ours.

SOP alignment
Repeatable processes that scale.
  • Template-driven deliverables
  • Version control discipline
  • Documentation traceability
QA audits
Prevention, not rework.
  • Audit planning support
  • CAPA-ready workflows
  • Inspection readiness posture
Risk-based monitoring
Targeted oversight with clear triggers.
  • Central monitoring signals
  • Site risk scoring
  • Documented decision trail
Data integrity
Clean outputs with defensible QC.
  • Reconciliation workflows
  • Query governance
  • Database lock readiness
Technology panel
EDC / CTMS / eTMF integrations
Data flow
Structured pipelines for cleaning, reconciliation, and review—mapped to your governance.
Alerts
Trigger-based notifications for protocol deviations, safety events, and site risk changes.
eCOA IRT Labs Safety DB eTMF
Validation support
Part 11-aligned controls and audit trails.
Discuss stack

Outcomes that speak in sponsor language

Anonymized examples showing how KaMma reduces operational friction and improves data readiness—without adding site burden.

Phase II • Multi-site
On track

Accelerated start-up through critical path clarity

Challenge: Variable country timelines and document cycles.

Approach: Standardized readiness checks + weekly gate reviews.

Result: Reduced activation variance and improved sponsor forecast accuracy.

Phase III • Global
Data focus

Cleaner data with fewer site disruptions

Challenge: Late query spikes and slow turnaround.

Approach: Query governance + centralized review cadence.

Result: Stable query volume and faster review cycles approaching lock.

Phase I • FIH
Safety

Safety reporting with a calm, documented cadence

Challenge: High sensitivity to reporting timelines.

Approach: PV workflows + reconciliation checkpoints.

Result: Consistent reporting and clear oversight trail for sponsors.

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About
KaMma Clinical Research

We’re a clinical research partner built around precision: clear process, accountable teams, and sponsor-ready communication—without losing the human touch that sites rely on.

Principle
Clarity
Fewer surprises through transparent planning.
Principle
Discipline
SOP-driven delivery and measurable quality.
Principle
Partnership
Sponsor goals + site realities aligned.
Leadership
Experienced functional leads across operations, data, and safety—focused on predictable execution.
KaMma Clinical Research leadership team portrait in a modern clinical office setting

Milestones that reflect operational maturity

A quiet, consistent build: repeatable processes, improved tooling, and expanding program complexity.

Milestone
Operational playbooks standardized
Unified handoffs across functions and consistent sponsor reporting.
Milestone
Quality management strengthened
CAPA-ready workflows and inspection-minded documentation practices.
Milestone
Technology and integration maturity
Flexible integration into sponsor stacks with better dashboard consistency.
Work with a team that owns deliverables
Clear roles, measured outputs, fast decisions.
Request a Proposal

Ready to scope a study with fewer surprises?

Share your protocol synopsis, timeline targets, and regions. We’ll respond with a practical plan, clear assumptions, and next steps.

Direct contact
We reply within 1 business day.
Prefer an NDA first? We can align on paperwork before detailed scoping.

Request a proposal

Provide a few details and we’ll come back with a structured response: scope options, assumptions, timeline, and a proposed delivery model.

What you’ll get
  • Clear scope + deliverables
  • Quality & tech approach
  • Practical timeline assumptions
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