Clinical Trial Registration & Result Disclosures Services

Remove the administration burden of registering your clinical trial protocol and disclosing your trials results.

At Quanticate we make sure that your clinical trial meets and exceeds the clinical trial result disclosure reporting requirements.

Our medical writers are experts in all forms of trial compliance including disclosure obligations. We can work across all major global registries including:

Our Services

We support you throughout the whole protocol registration and results disclosure journey. We have sophisticated processes and tools in place to enable our specialists to manage all of your disclosure needs across your full pipeline of studies.

Protocol (Trial) Registration

We excel in timely registration of all Applicable Clinical Trials (ACTs) on registries like clinicaltrials.gov, EudraCT, EU-CTIS so that you meet your obligation towards ICMJE (before FSFV), US FDA Final Rule (within 21 days of FSFV).

Specialists at Adapting to SOP Requirements

Our team is well experienced in disclosure requirements for all global registries and follow best practices and flexibility to adapt to sponsor SOPs.

Interface Integration

We can seamlessly work with interfaces like PharmaCM, adapting to your specific needs. In the absence of any interface, we also work directly on the registry portal of ClinicalTrials.gov and EU CTR.

Protocol Amendments and Progress Updates

We update the protocol amendments and status of the trial, as and when available, aligning to sponsor necessities and regulatory requirements. We also update the protocol registration with individual site status, overall recruitment status, primary completion date and other data elements on ClinicalTrials.gov.

Meeting Timelines

We sincerely help you to meet all the timelines for trial registration, trial maintenance, and results postings per applicable regulatory requirements especially per US FDA Final Rule and EU CTR.

Results Postings

We prepare and submit the results of all ACTs within 1 year of the primary completion date (for clinicaltrials.gov) and within 12 months from the LSLV for EudraCT or EU-CTIS.

Redactions

Our redaction specialists excel in redactions of clinical study protocols, statistical analysis plans (SAP) and other essential documents for regulatory compliance along with results postings.

Compliance Assessments

We evaluate compliance risks and identify any potential areas of concern in the operational process.

Avoiding Notices of Noncompliance and Civil Money Penalty Actions

The US FDA has the authority to issue a Notice of Noncompliance to a responsible party for failure to comply with certain requirements for registering and submitting results information to ClinicalTrials.gov.

National medicines regulators in seven major European Union countries now have legal powers to impose fines of up to EUR 250,000 on clinical trial sponsors that fail to make the results of drug trials public as required by law. We help you to comply with regulatory requirements and hence avoid penalties and fines associated with non-compliances.

The timely posting of summary results of clinical trials is an ethical and scientific obligation. At Quanticate, our Clinical Trial Disclosure team is driven by the goal of delivering value to our Sponsors, trial participants, and the public by responsibly sharing clinical trial information and data.

We are dedicated to reducing risk for our Sponsors and safeguarding patient privacy. Our aspiration is to become the preferred partner for Sponsors and be acknowledged as an industry leader in the realm of clinical trial disclosures.

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Team Leaders

Karen Ooms

Joint Chief Operating Officer

Karen Ooms is a Chartered Fellow of the Royal Statistical Society and has a background in biostatistics spanning over 25 years. Prior to joining Quanticate in 1999 (Statwood), Karen was a Senior Statistician at Unilever.