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Product Overview
ProtoCheck — Clinical Trial Protocol Compliance
ProtoCheck

Eliminate Clinical Trial Protocol Compliance Gaps Before They Delay Your Trial

ProtoCheck is the first tool that checks clinical trial protocols against FDA, EMA, ICH, and WHO regulations simultaneously — built for CROs and pharma sponsors with active Phase 2/3 protocols.
The Problem
60%
of clinical trials undergo at least one protocol amendment, costing $500K–$2M each. Most trace back to compliance gaps that manual, multi-authority regulatory review missed. Multiple Reviewers. Weeks and Months. Hundreds of pages. Compliance gaps still slip through.
What ProtoCheck Does
Flagship — Patent Pending
ProtoCheck ProtoCheck
Multi-reviewer protocol compliance, audit-ready in hours not weeks
Checks protocols against FDA, EMA, ICH, and WHO simultaneously
Scans 500+ regulatory citations in a single pass
Evidence chains — every finding cites its regulatory source
Deterministic output — same protocol, same results, audit-ready
Covers 6+ therapeutic areas (oncology, CNS, cardiology, dermatology, GI, infectious disease)
Upload a protocol → compliance score with traceable findings in hours, not weeks
How It Works — Your Data Is Safe
📄
Upload Protocol
PDF submitted
via HTTPS (TLS 1.2+)
→
⚙
Parse & Extract
Structure recognized
sections mapped
→
🤖
Multi-Authority Check
FDA • EMA • ICH • WHO
500+ citations scanned
→
📊
Compliance Report
Score + findings
with evidence chains
→
📝
Audit-Ready PDF
Traceable findings
ready for review team
✕ Your data never leaves your tenant scope
✕ Your data is never used for model training
✕ AI inference retains zero customer data
Nitin Bhatti
Nitin Bhatti
Founder & Platform Architect
25 yrs enterprise tech • 15 yrs Bristol Myers Squibb • J&J • TOGAF • PMP • MBA
Dr. Vishal Goyal
Dr. Vishal Goyal
Chief Medical Officer
18+ yrs Drug Development • Physician Scientist • Protocol Design • Regulatory Submissions
LinkedIn: linkedin.com/in/nitinbhatti
Web: orchestraprime.ai/products
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LinkedIn
Patent Pending Deterministic AI 500+ Regulatory Citations Multi-Authority AWS Cloud-Native North Brunswick, NJ
— Sample Analysis Outcome 1 of 2 —
ProtoCheckby OrchestraPrime · Protocol Compliance Intelligence
SAMPLE ANALYSIS · 500+ CITATIONS · PROTOCOL A

Protocol A — Neurology / Migraine Prevention

A Phase 3 randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of a subcutaneous monoclonal antibody for the preventive treatment of episodic migraine
Sponsor, protocol identifier, and study-specific details have been anonymized. Findings and regulatory citations are presented as produced by ProtoCheck.
Sponsor
[Major Pharma Sponsor]
Phase / Design
Phase 3
Randomized, Double-blind, Placebo-controlled
Regulatory Scope
FDA + ICH
500+ regulatory citations applied
Therapeutic Area
Neurology
Migraine prevention
Regulatory Citations
500+
Total Findings
14
Material Compliance
46.6%
By Authority
FDA 4 ICH 10
Critical2
High4
Medium7
Low1
# Rule ID Severity Type Section Finding Recommendation Conf
1 FDA-21CFR50.20
FDA		 CRITICAL missing Informed Consent The section does not explicitly state that informed consent must be obtained before the subject's participation in the research, nor does it mention that no exculpatory language may be included. Add explicit statement that informed consent shall be obtained from each subject or legally authorized representative prior to participation in the study, and that no informed consent may include exculpatory language through which the subject waives legal rights or releases the investigator, sponsor, or institution from liability for negligence. 0.98
2 FDA-21CFR50.25
FDA		 CRITICAL incomplete Informed Consent The section does not explicitly address all required elements of informed consent per 21 CFR 50.25, including: a statement that the study involves research, description of reasonably foreseeable risks or discomforts, description of benefits, disclosure of alternative procedures or treatments, confidentiality statement, compensation and medical treatment availability for injury, contact information for questions, and statement that participation is voluntary with no penalty for withdrawal. Add explicit reference to ensuring all eight basic elements required by 21 CFR 50.25(a) and six additional elements per 21 CFR 50.25(b) when applicable are included in the informed consent process and documentation. 0.95
3 FDA-21CFR11
FDA		 HIGH incomplete Source Data / Case Report Form The section describes electronic data transmission and direct entry into clinical databases but does not address 21 CFR Part 11 requirements for electronic records and electronic signatures, including audit trails, validation, security controls, and electronic signature requirements. Add explicit reference to 21 CFR Part 11 compliance requirements for electronic data capture systems. Include statements about system validation, audit trail capabilities, data integrity controls, and electronic signature requirements. 0.85
4 ICH-E6R2-4.8
ICH		 HIGH incomplete Signed Informed Consent Forms The section title indicates signed informed consent forms but the actual content does not describe the requirements for obtaining, documenting, or retaining signed informed consent forms. The content focuses on other study records and retention procedures. Add explicit content describing the requirements for signed informed consent forms, including: requirement to obtain written consent before any trial-related procedures, documentation that consent was obtained before enrollment, retention of original signed forms, and procedures for reconsenting if amendments affect consent. 0.95
5 ICH-E6R2-6.3
ICH		 HIGH incomplete Immunogenicity Endpoints The protocol section shows changes to study design elements (removal of blinding designation and changes to patient population descriptions) but does not provide adequate documentation of the impact on study conduct, patient safety, or data integrity. ICH E6(R2) 6.3 requires protocol deviations and amendments to be documented with assessment of impact. Include a comprehensive impact assessment for the design change, explaining how it affects the study's integrity, bias control, and data interpretation. Document any additional safeguards implemented. 0.82
6 ICH-E6R2-6.4
ICH		 HIGH missing Investigator Agreement The investigator agreement does not include a commitment regarding IRB/IEC approval. ICH-E6R2 section 6.4 requires that the investigator obtain IRB/IEC approval before beginning the trial and comply with IRB/IEC requirements. Add a statement such as: 'I agree to obtain approval from the IRB/IEC prior to initiating the study and to comply with all IRB/IEC requirements throughout the conduct of this trial, including reporting of amendments and adverse events as required.' 0.90
Key Findings
14 compliance gaps identified across FDA and ICH regulations. Informed consent sections carry the highest risk (2 critical findings). Data management and quality assurance sections show systemic incompleteness across multiple ICH E6(R2) requirements.
Severity Calibration
All severity levels calibrated by a physician-scientist with 18+ years of drug development experience. Critical findings (informed consent) reflect patient safety impact. Severity mapping is deterministic and reproducible across runs.
What This Means
Each finding represents an avoidable author-review iteration before IRB/EC submission. The 2 critical informed consent gaps would likely trigger regulatory queries. Addressing these proactively saves weeks of review cycle time.
Protocol A · Phase 3 Neurology / Migraine Prevention · 500+ citations · Anonymized Sample
OrchestraPrime · orchestraprime.ai
— Sample Analysis Outcome 2 of 2 —
ProtoCheckby OrchestraPrime · Protocol Compliance Intelligence
SAMPLE ANALYSIS · 500+ CITATIONS · PROTOCOL B

Protocol B — Oncology / EGFR+ NSCLC

A Phase 3 randomized, open-label study of a bispecific antibody plus tyrosine kinase inhibitor combination compared with standard of care in patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer
Sponsor, protocol identifier, drug names, and study-specific details have been anonymized. Findings and regulatory citations are presented as produced by ProtoCheck.
Sponsor
[Top-10 Pharma Sponsor]
Phase / Design
Phase 3
Randomized, Open-Label, Active-Controlled
Regulatory Scope
FDA + ICH
500+ regulatory citations applied
Therapeutic Area
Oncology
EGFR+ NSCLC
Regulatory Citations
500+
Total Findings
23
Material Compliance
49.5%
By Authority
FDA: 35% ICH: 65%
Critical1
High9
Medium10
Low3
# Rule ID Severity Type Section Finding Recommendation Conf
1 FDA-21CFR50.25
FDA		 CRITICAL incomplete Informed Consent Process The informed consent process description does not explicitly address all required elements of 21 CFR 50.25, specifically: a statement that the study involves research, the expected duration of participation, and all eight basic elements required by the regulation. Explicitly enumerate all eight basic elements required by 21 CFR 50.25(a) and six additional elements per 50.25(b) when applicable. Add specific language covering each element in the informed consent documentation. 0.95
2 FDA-21CFR11
FDA		 HIGH incomplete Data Quality Assurance / QC The section mentions eCRF review and data upload but does not address electronic records and electronic signatures requirements under 21 CFR Part 11, including audit trails, system validation, and security controls. Add explicit statements regarding compliance with 21 CFR Part 11 requirements including: system validation documentation, audit trail capabilities for all data changes, and electronic signature controls. 0.90
3 FDA-21CFR312.23-a3
FDA		 HIGH incomplete References The References section title indicates references were added for specific safety text but no actual bibliographic references are provided in the section content. FDA regulations require that protocol information be supported by appropriate references. Include complete bibliographic references for safety-related citations in proper format. Each reference should include authors, title, publication, year, and standard citation elements. 0.90
4 FDA-21CFR312.23-a3
FDA		 HIGH incomplete Study Rationale The rationale does not adequately summarize previous human experience with the investigational drugs as required by 21 CFR 312.23(a)(3)(iv). While a reference study with the standard-of-care comparator is mentioned, there is insufficient summary of prior clinical data for the investigational agents. Include a comprehensive summary of: previous clinical studies with the investigational drugs (indications studied, doses used, safety profile), relevant nonclinical findings, and the basis for the selected doses and combination approach. 0.82
5 ICH-E6R2-4.8
ICH		 HIGH incomplete IEC / IRB The section does not explicitly mention submission of protocol deviations, safety reports (SAEs/SUSARs), or annual/periodic reports to the IEC/IRB during the study, which are required under ICH-E6(R2). Complete the list of documents to be submitted during the study to include: protocol amendments, safety reports (SAEs, SUSARs, annual safety reports), protocol deviations, and recruitment updates. 0.85
6 ICH-E6R2-6.3
ICH		 HIGH incomplete Ethical Design Considerations The section does not explicitly describe the anticipated benefits for trial subjects or society that justify the risks and burdens, as required by ICH E6(R2) 6.3. The balance of benefits versus risks is not adequately addressed. Add an explicit statement describing the anticipated benefits to participants (e.g., potential therapeutic benefit, access to investigational treatment) and how these justify the known and potential risks of participation. 0.85
7 ICH-E6R2-6.4
ICH		 HIGH incomplete Investigator Agreement The investigator agreement does not explicitly mention the investigator's responsibility to maintain adequate and accurate source documents and trial records as required by ICH-E6(R2) Section 4.9. Add a statement such as: 'I agree to maintain adequate and accurate source documents and trial records in accordance with ICH-GCP requirements and to permit monitoring, audits, and inspections.' 0.75
8 ICH-E6R2-6.4
ICH		 HIGH incomplete Source Documents The section does not explicitly address procedures for ensuring accuracy, completeness, legibility, and timeliness of source documents, nor does it specify requirements for corrections/amendments to source records. Add explicit language requiring that source documents be accurate, complete, legible, and contemporaneous. Include specific requirements for making corrections: single line through, dated, initialed, with reason for change. 0.85
9 ICH-E6R2-6.4
ICH		 HIGH incomplete CRF Completion The section does not explicitly address audit trail requirements for eCRF entries, corrections, and alterations. ICH-E6(R2) 6.4 requires that systems with direct data entry provide audit trails to document all changes. Add explicit language stating that the eCRF system maintains a complete audit trail that records all data entries, corrections, and alterations, including the identity of the person making changes and timestamps. 0.85
10 ICH-E6R2-6.4
ICH		 HIGH incomplete Publication / Reporting ICH-E6R2-6.4 requires protocols to describe procedures for recording and reporting adverse events and intercurrent illnesses. The section references special reporting situations but does not describe the actual procedures, timelines, or responsible parties. Include complete procedures for special reporting situations: what constitutes a reportable event, timeframes for reporting, responsible parties, reporting mechanisms, and follow-up requirements. 0.85
Key Findings
23 compliance gaps identified across FDA and ICH regulations. This oncology protocol shows significant gaps in investigator agreement completeness, source document procedures, and CRF audit trail requirements — all high-severity areas under ICH-E6(R2).
Cross-Protocol Pattern
Both protocols share common gaps: informed consent completeness (FDA 21 CFR 50.25), electronic records compliance (21 CFR Part 11), and quality management system documentation (ICH-E6R2-5.5). These patterns suggest systematic areas where protocol authors can focus pre-submission review.
Protocol B · Phase 3 Oncology / EGFR+ NSCLC · 500+ citations · Anonymized Sample
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