Sirii Kayy

Sirii Kayy

@sirikayy89

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2026-08-17 09:26:47 · Translate ·

What Sponsors Should Know About FDA vs EU DCT Regulations

Introduction Decentralized clinical trials (DCTs) have moved from being an alternative trial model to an increasingly important part of modern clinical research. Telehealth visits, remote data collection, home nursing, electronic consent, wearable technologies, and direct-to-patient delivery can reduce participant burden and expand access to research. At the same time, decentralization...

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2026-08-11 05:34:55 · Translate ·

Navigating Annex 11 Compliance in an Increasingly Digital Clinical Environment

Introduction Digital transformation has changed how pharmaceutical companies, sponsors, CROs, and clinical research organizations manage regulated information. Cloud platforms, electronic records, automated workflows, remote access, and interconnected clinical systems have made research processes faster and more scalable. At the same time, they have increased expectations around system...

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2026-08-06 09:44:29 · Translate ·

Best Practices for Implementing ePRO and eCOA in Clinical Trials

Introduction Clinical trials increasingly rely on digital technologies to collect accurate, timely, and patient-centered data. Electronic patient-reported outcomes, commonly known as ePRO, and electronic clinical outcome assessments, or eCOA, allow sponsors and research teams to capture information directly from patients, caregivers, and healthcare professionals. When implemented effectively,...

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2026-08-03 09:53:09 · Translate ·

10 Leading CTMS Platforms for EDC and eTMF Integration

Introduction Modern clinical trials generate operational data, participant data, regulatory documents, monitoring records, and financial information across multiple systems. When these systems remain disconnected, study teams must repeatedly reconcile data, update spreadsheets, and manually transfer documents. Integrating a CTMS with electronic data capture and electronic trial master file...

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2026-07-31 12:12:38 · Translate ·

Choosing EDC Software: A Practical Guide for Sponsors and CROs

Introduction Clinical trials generate large volumes of complex data across multiple sites, participants, and study teams. Managing this information accurately is essential for protecting participants, maintaining regulatory compliance, and ensuring that study results are reliable. For sponsors and contract research organizations, selecting the right EDC software is therefore an important...

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2026-07-31 07:09:23 · Translate ·

ePRO or eCOA? Choosing the Right Approach for Clinical Trials

Introduction Digital technologies are transforming how clinical trials collect information from patients, caregivers, clinicians, and site teams. Two terms that frequently appear in this discussion are ePRO and eCOA. Although they are sometimes used interchangeably, they do not refer to exactly the same thing. Electronic patient-reported outcome tools focus specifically on information provided...

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2026-07-30 08:58:01 · Translate ·

Choosing the Right ePRO Software for Clinical Trials

Introduction Patient-reported data plays an increasingly important role in understanding how treatments affect symptoms, quality of life, daily functioning, and overall well-being. Traditionally, this information was collected using paper diaries, questionnaires, and site-based assessments. However, paper-based methods often create challenges such as missing entries, delayed reporting,...

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2026-07-29 09:31:19 · Translate ·

How to Ensure Data Integrity During EDC System Migration

Introduction Migrating clinical trial data from one Electronic Data Capture system to another is a complex process that requires careful planning, validation, and documentation. Clinical trial databases may contain thousands of subject records, audit trail entries, queries, forms, coding details, and supporting documents. Any error during migration can affect data reliability, regulatory...

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2026-07-28 10:12:52 · Translate ·

How eTMF Clinical Trial Software Reduces Document Management Risks

Introduction Clinical trials generate a large volume of essential documents, from protocols and investigator agreements to monitoring reports, safety documentation, training records, and regulatory correspondence. These documents provide evidence that a study was conducted in accordance with the approved protocol, Good Clinical Practice requirements, and applicable regulations. When trial...

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2026-07-28 07:06:18 · Translate ·

Clinical Trial eConsent Platforms: Top Solutions Compared

Introduction Informed consent is one of the most important ethical and operational processes in clinical research. Yet paper-based consent can create delays, version-control problems, incomplete signatures, and limited visibility for sponsors and sites. An econsent system replaces much of this manual work with a controlled digital process that helps participants review study information, ask...

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2026-07-24 06:11:40 · Translate ·

Clinical Document Automation: Transforming Regulatory and Medical Writing

Introduction Clinical research generates a large volume of complex documentation throughout the study lifecycle. Protocols, informed consent forms, safety narratives, statistical summaries, regulatory submissions, and clinical study reports must all be prepared with accuracy, consistency, and compliance. Traditionally, medical writers have created these documents through highly manual processes...

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2026-07-23 09:05:52 · Translate ·

How an eSource Platform Enables Real-Time Clinical Data Access

Introduction Clinical trials generate large volumes of data from site visits, patient assessments, laboratory tests, medical devices, and source documents. When this information is first recorded on paper and later entered into an electronic data capture system, research teams may experience delays, transcription errors, and additional verification work. An eSource platform changes this process...

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