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COTAENTERPRISES INC.
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EXPERTISE / CAPABILITIES

Where science meets
execution.

From the first scientific question to the final clinical study report, COTA connects biostatistics, programming, documentation and experienced guidance.

✳
BUILT AROUND
THE EVIDENCE.
A SCIENTIFIC PARTNER, NOT A TASK LIST

Every dataset tells a story.
We help make it defensible.

Clinical development requires more than producing tables or writing a report. It requires a chain of defensible decisions: what a trial is designed to demonstrate, how information is gathered, how endpoints are analyzed, how results are verified, and how findings are communicated.

Our team brings statistical judgment, analytical programming, and scientific writing together so the question asked in the protocol remains connected to the answer given in the report. We support focused deliverables or become an embedded specialist partner within your existing sponsor or CRO team.

Tell us about your program ↗
01 / DEFINEScientific questionProtocol & endpoints
02 / PLANAnalysis strategySAP & specifications
03 / EXECUTEValidated outputsDatasets & TFLs
04 / COMMUNICATEDecision-ready evidenceCSR & interpretation
01 / 05    BIOSTATISTICS & STUDY DESIGN

Design the study around the decision.

In clinical research, statistical decisions begin long before a database is locked. The choice of primary endpoint, comparison population, analysis framework and missing-data strategy can determine whether a result is interpretable at all. We help research teams connect clinical objectives to a study design that can answer the questions that matter.

Whether a sponsor is preparing its first Phase II protocol or refining a pivotal-study strategy, our role is to surface statistical assumptions early, document the trade-offs, and create a defensible plan that clinical, regulatory and operational colleagues can understand.

How we support your team

  • Protocol development and independent design review
  • Endpoint, estimand and sample-size considerations
  • Randomization, multiplicity and missing-data planning
  • Statistical analysis plans and independent statistical review
Discuss this capability ↗
ENDPOINT SIGNAL / ILLUSTRATIVE
BASELINEFOLLOW-UPTREATMENT SIGNAL
Pre-specified endpoint Comparator
02 / 05    CLINICAL SAS & DATA ANALYSIS

Turn data into reproducible evidence.

A useful statistical result must be traceable to its source. Our clinical SAS programming work links analysis specifications to derived datasets, tables, figures and listings. That means looking beyond whether code runs: are data transformations consistent, derivations documented, populations defined correctly and calculations independently reviewed?

We support both established data environments and studies with imperfect inherited workflows. The emphasis is on transparent analysis methods, logical programming specifications and repeatable quality control—not just producing a final PDF.

How we support your team

  • SAS-based analysis and programming specifications
  • Analysis dataset creation and CDISC alignment where scoped
  • Tables, listings and figures (TLFs/TFLs)
  • Independent programming QC, reconciliation and handoff
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TRACEABILITY / PROGRAMMING PIPELINE
SDTM / SOURCE DATASUBJID · TRT · AVAL · PARAMCD
↓ derivations↓ checks
ADaMAnalysis ready
QCIndependent
↓↓
TABLESFIGURESLISTINGS
TRACEABILITY FIRSTREPRODUCIBLE BY DESIGN
03 / 05    MEDICAL & SCIENTIFIC WRITING

Make the reasoning as clear as the result.

A well-written clinical document has to withstand close scientific reading. We help develop and refine protocols, statistical analysis plans, programming analysis plans and clinical study reports—connecting objectives, methods, analysis choices and interpretation in a consistent narrative.

Medical writing is not simply polishing language after the study. It is a discipline of explaining what was planned, what was observed, what uncertainties remain, and how the evidence should be interpreted without overstating the findings.

How we support your team

  • Clinical study protocols and amendments
  • Statistical and programming analysis plans
  • Clinical study reports (CSRs) and integrated interpretation
  • Cross-document consistency and technical review
Discuss this capability ↗
DOCUMENT ARCHITECTURE / DELIVERABLE CHAIN
01PROTOCOLObjectives · Endpoints
02ANALYSIS PLANMethods · Populations
03CLINICAL STUDY REPORTResults · Interpretation
ONE CONSISTENT SCIENTIFIC NARRATIVE
04 / 05    INDEPENDENT REVIEW & QC

Find the disconnects before they matter.

Small inconsistencies can become consequential when a project advances into submission preparation. An endpoint described differently in the protocol and SAP, a population flag derived incorrectly, or a table that is inconsistent with a CSR can create rework and uncertainty at precisely the wrong time.

We can provide an independent review perspective across scientific documents, datasets, programming outputs and handoffs. Scope is tailored to the specific study; quality review supports—but does not replace—a sponsor’s established quality system or regulatory responsibilities.

How we support your team

  • Protocol-to-SAP-to-TFL alignment checks
  • Independent programming and statistical review
  • Scientific narrative and methods consistency checks
  • Issue tracking, resolution and handoff documentation
Discuss this capability ↗
EVIDENCE ALIGNMENT / QC GRID
ELEMENT
PROTOCOL
SAP
OUTPUT
PRIMARY ENDPOINT✓✓✓ANALYSIS SET✓✓✓MISSING DATA✓✓REVIEWSENSITIVITY✓✓✓
ILLUSTRATIVE CHECKLIST · NOT REAL STUDY RESULTS
05 / 05    CLINICAL DEVELOPMENT ADVISORY

Bring senior perspective to the difficult moments.

Sponsors and CRO teams often need specialized guidance at a critical inflection point: before a major protocol decision, during a complex data review, when a planned analysis becomes problematic, or while preparing explanations of results for stakeholders. We help organize evidence, identify unanswered questions and chart practical next steps.

Our work can be an independent technical assessment, a collaborative design discussion, or temporary statistical and programming support alongside an existing team. We help sponsors understand the evidentiary implications of their options; we do not claim to guarantee an approval outcome or replace regulatory counsel.

How we support your team

  • Inherited study and program assessment
  • Data-quality and analytic readiness review
  • Protocol or analysis-plan reconsideration
  • Scientific due diligence for biotech, pharmaceutical and investor teams
Discuss this capability ↗
DECISION PATH / SCIENTIFIC ADVISORY
DEFINE THE QUESTION
REVIEW THE EVIDENCE
IDENTIFY GAPS & OPTIONS
DOCUMENT NEXT STEPS
ADVISORY DOES NOT PREDICT REGULATORY OUTCOMES
DELIVERABLES THAT CONNECT

From hypothesis to
the final report.

Each step can stand alone—or fit within a single coordinated program. Engagements are scoped to your data environment, internal quality framework and decision-making needs.

Submit a project brief ↗
01ProtocolWhat are we trying to establish?
02SAP / programming planHow will we analyze and verify the data?
03Analysis datasets & TFLsWhat does the evidence actually show?
04Clinical study reportHow can findings be interpreted responsibly?
WHEN REVIEW MATTERS

Regulatory scrutiny is a reminder to plan ahead.

Read selected 2026 regulatory case studies—including FDA complete-response letters and EMA negative opinions—and see the broader study-design lessons.

REGULATORY OUTCOMES

Every major regulatory question eventually becomes a question about evidence.

Examples involving endpoint selection, study robustness, benefit-risk analysis and incomplete applications show why early statistical rigor and transparent interpretation matter. We do not imply COTA was involved in these matters.

Explore recent examples ↗
SERVICE SCOPE Specific deliverables, coding standards, quality practices and regulatory responsibilities are defined in each engagement. Visuals on this page are conceptual demonstrations, not clinical datasets or COTA study results.
LET'S BUILD THE RIGHT STUDY

Good science deserves
great execution.

Bring us the question, the protocol, or the challenge. We'll help map the next move.

Discuss your project ↗