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myLaminin Perspectives


Managing Protocol Deviations and Amendments in Multi-Site Clinical Trials at Scale
earn how sponsors can manage protocol deviations, amendments, eTMF documentation, and regulatory compliance in multi-site clinical trials under evolving ICH E6(R3) expectations.

myLaminin
May 257 min read


ICH E6 (R3) Is Reshaping Clinical Trials. Here’s What Sponsors, CROs, and Research Sites Need to Know
Learn how ICH E6 (R3) is reshaping clinical trials through risk-based quality management, decentralized research oversight, data integrity, and continuous inspection readiness across global clinical research operations.

Deanne Bassili
May 115 min read


The Hidden Operational Burden of Running Clinical Trials Without a Clinical Trial Management System
Running clinical trials without a Clinical Trial Management System (CTMS) creates hidden operational burdens, from fragmented data and compliance risks to poor collaboration and reduced patient engagement. Disconnected tools like spreadsheets and email slow execution, increase errors, and threaten data integrity. A centralized CTMS streamlines workflows, ensures regulatory compliance, and improves trial efficiency, making it essential for scalable, secure, and successful clin

Darina Dragouleva
Apr 153 min read


Spreadsheet-Driven Trials: Why Excel Still Creates Risk in Clinical Research
Spreadsheet-driven clinical trials introduce hidden risks in compliance, data integrity, and efficiency. While Excel remains a convenient tool, it often evolves into ungoverned infrastructure, creating version control issues, audit gaps, and costly delays. Modern CTMS platforms like myLaminin help research teams reduce spreadsheet dependency, strengthen governance, and streamline workflows without sacrificing flexibility in complex, data-intensive studies.

Jagdeep Saran
Apr 134 min read
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