Turning complex data into clear evidence for regulatory success
Our multidisciplinary teams have extensive experience delivering Integrated Summaries of Safety (ISS), Efficacy (ISE), and Immunogenicity (ISI) that meet global regulatory expectations.
From early planning to final submission, we provide a full-service journey tailored to your needs. We lead the way, providing expert guidance to help you align complex datasets, highlight the most important insights, and navigate integration challenges across studies.
When timelines slip or data quality is at risk, you can count on us to act fast. We’ve successfully rescued submissions delayed by inconsistent CRO delivery or poor data, ensuring everything is delivered on time and fully compliant.
You’ll benefit from a smooth, reliable service backed by robust SOPs, dedicated QA oversight, and zero-audit findings record, which has earned us the reputation of best-in-class submission support.
We provide flexible resourcing models that adapt to your needs, whether you’re scaling up across multiple studies or need targeted expertise fast.
Get the same expert team to support both your main studies and integrated analyses. This continuity ensures a seamless transition between studies to reduce risk, maintain study knowledge, and enable faster, more efficient submissions.
Accelerate Study Success: Automate Workflows, Future-Proof Results, and Streamline Delivery
Accelerate Study Success: Automate Workflows, Future-Proof Results, and Streamline Delivery
Accelerate Study Success: Automate Workflows, Future-Proof Results, and Streamline Delivery
Accelerate Study Success: Automate Workflows, Future-Proof Results, and Streamline Delivery
Accelerate Study Success: Automate Workflows, Future-Proof Results, and Streamline Delivery
Accelerate Study Success: Automate Workflows, Future-Proof Results, and Streamline Delivery
Integrated analysis and submission involves harmonizing data across multiple studies to produce comprehensive summaries, such as ISS, ISE, and ISI, that meet global regulatory standards and support successful submissions to agencies like the FDA and EMA.
Veramed provides integrated SAPs, data standardization and mapping to SDTM/ADaM, regulatory strategy consulting, QC and validation, and submission-ready outputs including tables, listings, and figures, all backed by robust SOPs and QA systems.
Veramed ensures compliance through expert consulting aligned with FDA/EMA requirements, CDISC-compliant data formatting, and audit-ready packages validated by internal QA systems. Our track record includes zero audit findings and 100% repeat business.
Yes, Veramed specializes in rescuing submissions that are off-track due to inconsistent CRO delivery or data issues. Our rapid-response teams ensure timely, compliant delivery with precision and quality.
Veramed supports Phase I–IV clinical trials and real-world evidence (RWE) studies. We’ve completed over 150 analyses and 15+ successful submissions across the clinical development lifecycle.
Veramed assigns consistent expert teams across main studies and integrated analyses, ensuring continuity, reduced risk, and faster, more efficient submissions. This approach supports knowledge retention and smooth transitions from database lock to submission.
Our premium service is backed by dedicated QA oversight, robust SOPs, and a zero-audit findings record. Clients benefit from smooth, reliable delivery and expert guidance throughout the submission process.
