Questions and answers

An export of the TMF with a defined cutoff date, and additional related study documents, such as the TMF Plan.

We analyze what is missing. If you provide an expected-document list, we also compare the TMF against it.

Before the review starts, we agree on the objective, scope and method in a written plan.

The review covers the records you provide as of the established cutoff date. The checks depend on the established scope, the records you supply, and the information available: the report names any records or checks we could not assess.

VCS Surveyor™ processes the supplied documents and applies checks according to the document type and available information.

No. You never log in to or run software. We operate it. You receive findings assessed by our reviewers.

No. We do not change your records. They stay the official record.

No. A TMF Review from VCS is an assessment with reviewed findings and recommended actions. We also perform formal TMF audits as a separate service, with their own agreed scope. After an audit, we can issue an audit certificate.

The review gives you a clear picture of the condition of your TMF and what needs attention before an inspection. We identify potential gaps, explain the evidence behind them, prioritize areas of concern, and recommend actions your team can take to address them.

No review can guarantee how an inspector will assess a TMF or that an inspection will have no findings. Our goal is to help you identify and resolve issues before they are found during an inspection.

Yes. Start with one study or several. After a short scoping conversation, we send you a written proposal with the scope and deliverables.

We deliver our reviews in English. For records in other languages, we first review representative documents and agree with you what we can review, and how.

Only highly experienced TMF professionals. Our reviewers investigate the flagged items and the questions in the plan, weigh the evidence and decide what is a real issue.

They apply the protocol, the TMF Plan and the stage of the study, explain what matters and write recommendations.

No. VCS Surveyor™ raises signals: potential findings a reviewer should examine. Each examination ends in one of four conclusions.

• Confirmed finding. With its supporting evidence and the basis for the assessment.
• Open question. We state it clearly, with what it takes to resolve it.
• Assessment limitation. What we could not assess, and why.
• No issue. A false alarm, or something the study context explains.

The report keeps findings, open questions and limitations apart, so you see at a glance what we concluded and what is still open.

We report which of these applies:

• Not found in the records provided. Stated with the cutoff date and the records we reviewed.
• Confirmed missing. Against an expectation that applies to this study at this stage.
• Held elsewhere. Once confirmed, we record where it is held.
• Not assessable. We could not read the record, or the information we needed was missing.

An expected-document list or TMF Plan guides the review. On its own, it does not prove what must exist at every point in a study.

We report unreadable files and missing inputs as not assessable.

Yes. You review the draft for factual accuracy. We consider corrections and retain responsibility for the final findings.

VCS Surveyor™, our software, sorts the documents using the TMF Reference Model, compares them with what should be there, runs checks and flags items for review.

Potential findings include:

• Expected documents not found at a study milestone
• Protocol numbers that do not match the study
• Regulatory and site dates out of sequence
• Duplicate documents
• Late filing, from the filed dates you supply
• Monitoring visit cadence and gaps
• IRB approval coverage and continuing review
• Investigator essential documents
• Sites that do not match your CTMS

Some checks need inputs from you, such as an expected-document list, filed dates or a CTMS extract.

Each flagged item links to its documents, and VCS Surveyor™ records every reviewer decision, with who made it and when.

AI helps classify documents and identify records that may need attention. We test these functions, and our reviewers assess the evidence before any finding is reported.

We set these controls using the FDA’s risk-based framework for AI credibility.

We stand behind the assessments we deliver. VCS Surveyor™ helps our experts identify potential issues; our reviewers assess the evidence, determine the findings, and explain what needs attention. You receive findings supported by evidence and expert judgment—not unreviewed software output.

We comprehensively test VCS Surveyor™ against known problems in synthetic TMFs, measuring what it detects, what it misses, and where it raises false alarms. We continue to optimize it to achieve appropriate levels of accuracy and consistency.

We do not represent VCS Surveyor™ as a validated GxP computerized system. We qualify each release before we use it for customer work, through documented testing against defined acceptance criteria. Our own staff operate it; you receive our review service and do not operate the software.

Our assessment concludes that Part 11 does not apply in our defined context of use. We reassess it if that context changes.

• Each customer’s data is held in its own cloud project, database and storage, in the region agreed for the engagement. A small number of named VCS platform operators can reach it for administration; that access is controlled and logged.
• Reviewers can open documents only for studies they are assigned to, and each opening is logged.
• What is sent to the AI is extracted text and coded metadata, not your original files.
• We do not train AI models on your content or reuse it for other customers.
• By default, text goes to the AI with names intact, because the review depends on matching names across records. A customer can ask us to mask identifiers for their engagement. Masking replaces selected identifiers; it does not make the data anonymous.
• We sign a data processing agreement for every engagement, and a business associate agreement where a HIPAA covered entity is upstream.

No. We do not hold ISO 27001 certification or a SOC 2 report. We run an information security management system and a quality system under controlled, approved documents, and share our security and data-protection documentation with customers under a confidentiality agreement.

Your protocol, and the operational plans that shape how the trial runs, such as the monitoring plan, data management plan and patient-facing instruments. We agree on the exact inputs in the proposal.

You receive a Data Quality Risk Assessment (DQRA) documenting the risks, recommended actions, and what to monitor, together with simulator results where the model applies.

No. You receive an assessment of your protocol with recommended actions, not a rewritten protocol.

Our assessments draw on published evidence and expert judgment.

Our Chief Scientific Officer, Dr. Nathaniel Katz, has been a leading researcher on the impact of study conduct and measurement error on trial outcomes for the last 20 years, in concert with FDA public-private partnerships such as IMMPACT. At Analgesic Solutions, the first company he founded, he led the development, validation, and commercialization of a suite of tools to reduce measurement error in clinical trials, including central statistical monitoring, which led to that company’s acquisition. VCS represents a continuation of that work with ever more sophisticated tools.

His publications include:

Trial conduct and data quality

• Identified ways to improve study conduct and data quality in chronic pain trials, since weaknesses in conduct may explain why many phase 3 trials fail (IMMPACT recommendations). The Journal of Pain, 2020
• Gave practical, evidence-based suggestions for designing and running confirmatory chronic pain trials that minimize measurement error. PAIN Reports, 2021
• Showed that the number of study sites affects the observed treatment effect size in opioid trials for chronic pain. Journal of Pain Research, 2019
• Reviewed the design features of opioid trials for chronic pain that may be associated with failing to separate drug from placebo. Neurology, 2005
• Reviewed methods for measuring symptoms and side effects in chronic pain trials, and their trade-offs. Contemporary Clinical Trials, 2012
• Compared electronic diaries with paper diaries and phone interviews for monitoring chronic pain over a year. PAIN, 2001

Placebo response, expectations and pain reporting

• Found that training patients to report pain accurately reduced the placebo response in a randomized trial. PLOS ONE, 2018
• Found lower placebo responses in a chronic low back pain trial that trained patients in accurate pain reporting, compared with similar trials without training. The Clinical Journal of Pain, 2020
• Developed the focused analgesia selection test (FAST), which measures how accurately patients report pain. Journal of Pain Research, 2017
• Examined how variability in pain reporting relates to the placebo response in a naproxen trial in knee osteoarthritis. PAIN, 2019
• Reviewed the methods of controlling the placebo response that have been tested in randomized trials. Contemporary Clinical Trials, 2021
• Related the size of the placebo response to the observed treatment effect and to failure to meet the primary endpoint in migraine prevention trials. Cephalalgia, 2021
• Showed why patients' expectations for improvement can add variability to chronic pain trials, and called for measuring them. The Journal of Pain, 2023
• Compared placebo and treatment responses in postherpetic neuralgia and diabetic neuropathy trials. PAIN, 2010

Assay sensitivity, outcome measures and trial design

• IMMPACT recommendations for improving assay sensitivity: a trial's ability to show that an effective treatment beats placebo. PAIN, 2012
• Identified patient, study and site factors associated with assay sensitivity across 200 neuropathic pain trials. Neurology, 2013
• Identified patient, study and site factors associated with assay sensitivity across 171 osteoarthritis pain trials. Arthritis & Rheumatology, 2014
• Examined whether variability in patients' baseline pain diaries affects assay sensitivity, using data from 12 neuropathic pain trials. PAIN, 2014
• Found a larger treatment effect in patients whose baseline pain scores agreed across two pain scales. Pain and Therapy, 2022
• Updated IMMPACT guidance on the pain intensity patients should have to enter a chronic pain trial. PAIN, 2023
• Compared how responsive different outcome measures are to treatment effects in osteoarthritis trials. Osteoarthritis and Cartilage, 2011
• Found that staircase-evoked pain may detect analgesic effects more sensitively than traditional pain assessments. The Clinical Journal of Pain, 2019
• IMMPACT recommendations on research design for confirmatory chronic pain trials. PAIN, 2010
• Outlined an evidence-based approach to designing chronic pain drug trials (ACTION). PAIN, 2011

It depends on the protocol and the inputs you can share. We give you a timeline in the proposal, after the scoping conversation.