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CDISC Implementation: Traceability from SDTM to ADaM

Understanding CDISC Standards in Clinical Research: A Practical Guide

Andrew Myslivets
Clinical research generates a large amount of data: protocol-defined assessments, CRF data, laboratory results, adverse events, exposure records, endpoint data, statistical analysis datasets, tables, listings, figures, metadata, and regulatory submission packages. Without standards, every sponsor, CRO, vendor, and system may…
FSP (Functional Service Provider) refers to an outsourcing model

What is a Functional Service Provider (FSP) in Clinical Research?

Andrew Myslivets
How does a CRO interact with a sponsor? What is project-based delivery, what is FSP, and what hybrid models sit between them? What do the evidence – and real delivery practice – suggest for biometrics teams? In clinical development, outsourcing…
ICH E6(R3) Principles 10-11

GCP in Practice: Principles 10-11 of ICH E6(R3)

Andrew Myslivets
We’re closing our E6(R3) series with two principles that most often decide whether execution stays clean: role clarity and IP/blinding traceability. 10) Roles and responsibilities (clarity + oversight) Key roles, interfaces, and responsibilities should be clearly defined and documented appropriately…
ICH E6(R3) Principles 7-9

GCP in Practice: Principles 7-9 of ICH E6(R3)

Andrew Myslivets
Now we move from design principles to making execution feasible and ensuring the results are reliable. 7) Risk-proportionate trial conduct (avoid unnecessary burden) Processes should be proportionate to risks to participants (including risks beyond usual care where relevant) and to…
ICH E6(R3) Principles 4-6

GCP in Practice: Principles 4-6 of ICH E6(R3)

Andrew Myslivets
In the last post we covered Principles 1-3 (ethics, consent, independent review). Now we move to the reliability backbone of trial evidence: science, people, and quality by design. 4) Scientifically sound trials (and periodic review) Trials should be scientifically sound…
ICH E6(R3) Principles 1-3

GCP in Practice: Principles 1–3 of ICH E6(R3)

Andrew Myslivets
We’re starting the series on the 11 principles of ICH E6(R3). E6(R3) consolidates and reframes the 13 principles from E6(R2) into 11 with clearer emphasis and more practical expectations. 1) Ethical conduct and participant protection (Declaration of Helsinki) Clinical trials…
GCP in practice ICH E6(R2) to E6(R3)

GCP in Practice: ICH E6(R2) → E6(R3) – why this update matters

Andrew Myslivets
The revision from ICH E6(R2) to E6(R3) was long overdue. Here’s what changed and what it means in practice. Context R2 (2016) strengthened oversight: centralized monitoring, risk-based quality management, and clearer sponsor responsibilities. Since then, trials have become more digital…
FDA‘s recent guidelines

TUNECT CRO deciphers the FDA’s latest guidance

Andrew Myslivets
TUNECT is at the forefront of embracing the FDA‘s recent guidelines on the use of Data Monitoring Committees in clinical trials. We’re excited to share our innovative approach to interpreting these standards through comprehensive flowcharts. Stay tuned as we navigate…
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