Post Marketing Research
CLOUDBYZ Blog » Clinical Research
by Reeshav Mittal
1y ago
Premarketing drug studies vs Post- Marketing research Premarketing drug studies consist of phase I-III trials, and are represented by pharmacokinetic and pharmacodynamic studies, dose ranging studies, and Randomized Controlled Trials (RCTs). Approximately only 20 % of the drugs that enter phase I are approved for marketing. Post-marketing research is a generic term used to describe all activities after drug approval by the regulatory agencies, such as the Food and Drug Administration (FDA). Other regulatory agencies, such as the European Medicines Agency (EMA), use the term post-authorization ..read more
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FDA Guidance for Industry: Providing Regulatory Submissions in Alternate Electronic Format
CLOUDBYZ Blog » Clinical Research
by Reeshav Mittal
1y ago
Issue Date: 24Jun2022   The US Food and Drug Administration has recently issued a final guidance for sponsors and applicants who receive an exemption or a waiver from providing regulatory submissions in electronic common technical document (eCTD) format.   In section 745A(a) of the FD&C Act, Congress granted FDA the authority to implement the Agency’s statutory electronic submission requirements in guidance. In response to this authorization, FDA implemented binding guidance requiring submission of new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain d ..read more
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White Paper: Understanding Patient Recruitment and Retention 
CLOUDBYZ Blog » Clinical Research
by Reeshav Mittal
1y ago
Author:  Reeshav Mittal, Associate Director, Clinical Operations, Cloudbyz Inc. Co-author: Medha Datar, Director, Clinical Solutions, Cloudbyz Inc.   Table of Contents Introduction What is RECRUITMENT? – SOME DEFINITIONS Major Critical Barriers to Patient Recruitment Retention in Clinical Trials How to Remove Recruitment & Retention Roadblocks Conclusion   Introduction Nothing is of more importance  to a clinical research study than recruitment and retention of participants in the study. In addition, losses to follow-up can destroy a study. Even those that succeed oft ..read more
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Regulatory Compliance Coverage & Reference between FDA 21 CFR Part 11 and EU Annex 11
CLOUDBYZ Blog » Clinical Research
by Bernadette Datka
2y ago
Until recently, clinical trials have been performed in a mostly paper-based processes. Advancements in technology, surge in remote work and digitization of the processes is driving the clinical research industry and consequently, there is increased use of electronic records and electronic signatures to support these processes. Though the regulations around electronic records and signatures, such as FDA 21 CFR part 11 and EU Annex 11, have been published for a long time, their application has amplified manyfold in the recent times. To ensure continued compliance to these regulations ..read more
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Core eTMF Features and Practices
CLOUDBYZ Blog » Clinical Research
by Grace Anderson
2y ago
On April 13th, Cloudbyz hosted a webinar covering Core eTMF Features and Practices. Our in-house experts, Medha Datar and Reeshav Mittal explained in detail what an eTMF is, the benefits and core features of an eTMF, compliance requirements, as well as how to choose the right eTMF vendor. The Cloudbyz eTMF solution offers a cloud-based repository of all your clinical trial documents including files, images, information, etc. Digitally capture, manage, share, and store all clinical trial-related documents with a centralized overview. Manage essential trial documents, stay inspection ..read more
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Solving Regulatory Challenges: CSV for Cloud-based Clinical Applications
CLOUDBYZ Blog » Clinical Research
by Saikat
2y ago
A comprehensive session exploring the regulatory challenges for clinical application.  Rajendra Sadare, Head – Quality & Compliance from Cloudbyz goes deeper to explain the challenges, the expectation and the possible solutions. Watch the recorded session here ..read more
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Cloudbyz & Pharmetique Labs: Solving Challenges in Pharmacovigilance
CLOUDBYZ Blog » Clinical Research
by In-house Team
2y ago
A comprehensive session exploring how Cloudbyz Pharmacovigilance solution was deployed to address Pharmetique Lab’s business challenges and some of the lessons learned along the way. Dr. Melissa Bernal Salazar, Director of Pharmacovigilance at Pharmetique Labs joined the session as a guest speaker to share her experiences.  Pharmetique Labs, a global leader in the manufacture of pharmaceutical products with over 25 years serving Latin America, was experiencing challenges when it came to their pharmacovigilance practice. Pharmetique Labs were looking for a way to centralize, simplify, an ..read more
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Cloudbyz & Pharmetique Labs: Solving Challenges in Pharmacovigilance
CLOUDBYZ Blog » Clinical Research
by In-house Team
2y ago
Pharmetique Labs, a global leader in the manufacture of pharmaceutical products with over 25 years serving Latin America, was experiencing challenges when it came to their pharmacovigilance practice. Pharmetique Labs were looking for a way to centralize, simplify, and optimize their pharmacovigilance processes on a single, cloud-based platform. Join a discussion between Cloudbyz and guest speaker Dr. Melissa Bernal Salazar, Director of Pharmacovigilance at Pharmetique Labs as we explore how the Cloudbyz Pharmacovigilance solution was deployed to address their specific business challenges and ..read more
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Patient Engagement in Clinical Trials: Tech Enhancements
CLOUDBYZ Blog » Clinical Research
by Abdallah Al Alfy
2y ago
The success of clinical trials depends on multiple factors. Only a handful of those factors however, are irreplaceable. Factors being irreplaceable means that no amount of alternative resources can make the trial successful. Patient engagement is one such irreplaceable factor. Engaging patients is necessary throughout the entire clinical trial. It begins with recruitment and ends with the study’s conclusion. That’s why recruitment is often grouped with retention in industry literature. In the past, while some trials faced issues engaging their patients that could have been addressed, many tri ..read more
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Wearables in Clinical Trials: An Overview of Challenges
CLOUDBYZ Blog » Clinical Research
by Abdallah Al Alfy
2y ago
Wearable Tech-What’s It All About? Let’s start from the very beginning. What are people talking about when they say “wearables”, “wearable biosensors”, “wearable devices”, or “wearable technology” in clinical trials? In the most basic sense, all these terms refer to relatively mobile devices that you can wear on your person; designed to measure specific biological parameters in your body. Today, the most obvious example of wearable technology might be something like a fitness tracker worn on your wrist. Some of the cheaper options might exclusively measure your heart rate, whereas more high-e ..read more
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