Contract Research Organization

Pinnacle 21 Reporting & Issue Resolution

We produce detailed Pinnacle 21 reports that identify and diagnose issues with your Define.xml and related datasets. Our experts compare your files against the latest data and submission standards, addressing errors and warnings to ensure a smooth regulatory review.

Define.xml Development & Validation

We generate and validate Define.xml files using Pinnacle 21 Enterprise (now Certara). Our team ensures that your metadata meets the most recent CDISC standards and technical conformance guidelines, reducing errors and accelerating the submission process.

Beyond Define.xml, we develop complete electronic Case Report Tabulation (eCRT) packages—including Study Data Reviewer's Guides (SDRG), Analysis Data Reviewer's Guides (ADRG), and BIMO documentation—as required by regulatory agencies. Our packages are developed in accordance with FDA technical conformance guidelines and tailored to your specific submission needs.

Comprehensive eCRT Package Development
Regulatory Submission Support

Our involvement doesn’t end with data preparation. We actively participate in FDA submission meetings, provide support during data audits, and help resolve data-related queries during NDA/BLA/IND review cycles, ensuring your submission is both robust and compliant.

Flexible Delivery Models: We offer end-to-end development and validation services. Whether you provide us with compliant datasets and metadata files, or request support using your internal systems.

  1. On-Platform Execution (Sponsor Resources)

    • We work directly within your secure environment using your systems and documentation

    • Ideal for teams with internal compliance systems but limited bandwidth

  2. Standalone Execution

    • You provide us with all compliant .xpt files, aCRF, specs, and related documents

    • We generate P21 reports, investigate issues, and deliver Define.xml + reviewer’s guide content

We deliver a fully validated, well-documented, and audit-ready eCRT package you can confidently include in your FDA, PMDA, NMPA, NDA, BLA, or IND submission.

Annotation of Unique blank CRF

We specialize in performing accurate and regulatory-compliant annotations of unique blank Case Report Forms (CRFs) based on CDISC SDTM standards. Our team ensures each data point is properly linked to the corresponding SDTM variables, controlled terminology, and domains, creating an FDA-compliant aCRF in PDF format.

Validation & Double Validation

Thorough quality review to meet the highest standards of data integrity, traceability, and compliance. We offer both Validation and Double Validation services for your clinical study metadata and documentation. An independent second layer of validation performed by a different programmer or team, ideal for critical submissions.

Expert Staffing

We specialize in IT staffing and consulting for diverse industries.

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Tailored Solutions

Our tailored solutions ensure the right fit for clients and candidates.

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Industry Focus

We focus on engineering, IT, clinical SAS, pharma, and biotech sectors.

Client Feedback

Hear what our clients say about our staffing and consulting services.

The team at Staffing and Consulting truly understands our needs. Reliable and efficient.

Michael Smith
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A person stands in a professional setting holding a blue folder. They are wearing a teal blazer over a white shirt and jeans. The background features glass walls and what appears to be a server room with blue lighting, suggesting a technological or business environment.

San Francisco

Partnering with this staffing firm enhanced our hiring process significantly. Highly recommend their expertise.

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A charming reception entrance with a wooden door and a sign above that reads 'RECEPTION' along with business names and phone numbers. The facade features yellow walls with brick accents. Inside, there is a small reception area displaying various bottles and items on white shelves under soft lighting.
Laura Johnson

New York

★★★★★
★★★★★
Solutions

Clinical Submission Excellence: Global Compliance, Expertise & Precision, Accelerated Timelines, Collaborative Approach

Partners

Connect

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