ProRelix Research https://prorelixresearch.com/ Clinical Research Organisation - 9001:2015 ISO Certified Company Wed, 19 Mar 2025 07:21:10 +0000 en-US hourly 1 https://wordpress.org/?v=6.7.2 https://prorelixresearch.com/wp-content/uploads/2017/08/favicon.png ProRelix Research https://prorelixresearch.com/ 32 32 FDA Validation Rules for Submission Data: Avoid Costly Mistakes! https://prorelixresearch.com/fda-validation-rules-for-submission-data/ Wed, 19 Mar 2025 06:28:29 +0000 https://prorelixresearch.com/?p=10819 FDA Validation Rules for Submission Data are essential for regulatory compliance. Learn about FDA data submission requirements, validator rules, study data standardization plans, and Pinnacle 21 validation. Stay updated with […]

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]]> The Role of Integrating E-Clinical Technologies In Smarter Clinical Trials https://prorelixresearch.com/the-role-of-integrating-e-clinical-technologies-in-smarter-clinical-trials/ Wed, 05 Feb 2025 11:06:49 +0000 https://prorelixresearch.com/?p=10791 Integrating E-Clinical Technologies in smarter clinical trials improves efficiency, enhances data accuracy, and streamlines clinical research for better patient outcomes. With the increasing world population, clinical trials are now more […]

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]]> Clinical Trials: Information for Patients and Caregivers https://prorelixresearch.com/clinical-trials-information-for-patients-and-caregivers/ Fri, 15 Nov 2024 11:39:43 +0000 https://prorelixresearch.com/?p=10472 Patients are the heart of all clinical trials ranging from recruitment, retention, protocol adherence, assessments, and safety data, making it necessary to ensure that patients are well-informed on trial protocol, […]

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]]> Clinical Trials and Human Subject Protection as per US FDA https://prorelixresearch.com/clinical-trials-and-human-subject-protection-as-per-us-fda/ Tue, 05 Nov 2024 10:21:25 +0000 https://prorelixresearch.com/?p=10466 Clinical trials are necessary in advancing medical research and health care options by allowing new treatments to be introduced in the market through safety and efficacy testing in humans. Successful […]

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]]> Understanding Clinical Data Management Services in Clinical Trials: A Breakdown https://prorelixresearch.com/understanding-clinical-data-management-services-in-clinical-trials-a-comprehensive-breakdown/ Wed, 09 Oct 2024 11:06:07 +0000 https://prorelixresearch.com/?p=10451 Understanding Clinical Data Management Services in Clinical Trials: A Breakdown, including study design and planning, data collection and validation, data monitoring and cleaning, database lock and archival, and regulatory submissions […]

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]]> Understanding Biostatistical Services in Clinical Trials: A Comprehensive Breakdown https://prorelixresearch.com/understanding-biostatistical-services-in-clinical-trials-a-comprehensive-breakdown/ Tue, 24 Sep 2024 12:00:52 +0000 https://prorelixresearch.com/?p=10437 Biostatistics involves the application of statistical techniques for the design and analysis of clinical trial data. In addition to the conduct of trials which encompasses regulatory approval processes, informed consent, […]

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]]> Telemedicine: How Remote Monitoring is Changing Clinical Research https://prorelixresearch.com/telemedicine-how-remote-monitoring-is-changing-clinical-research/ Mon, 02 Sep 2024 06:42:37 +0000 https://prorelixresearch.com/?p=10431 Clinical trials are undergoing a paradigm shift from a site-centric or traditional approach wherein the patients are required to go to central sites for consent processes, assessments, and safety monitoring […]

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]]> Putting Patients First: The Shift Towards Patient-Centric Clinical Trials https://prorelixresearch.com/putting-patients-first-the-shift-towards-patient-centric-clinical-trials/ Mon, 19 Aug 2024 06:07:28 +0000 https://prorelixresearch.com/?p=10425 Although time, speed, and operational constraints have long plagued the progress of clinical trials, another factor that remains important and has been gaining prime importance as the centre of clinical […]

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]]> CDISC Standards for Biostatistics and Clinical Data Management https://prorelixresearch.com/cdisc-standards-for-biostatistics-and-clinical-data-management/ Fri, 05 Jul 2024 04:56:28 +0000 https://prorelixresearch.com/?p=10355 Collating and integrating data from a myriad of sources especially in global clinical trials requires that the data be in an accurate, reliable, and consistent format. The application of standards […]

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]]> Food and Dietary Supplements Clinical Trials Regulations in USA https://prorelixresearch.com/food-and-dietary-supplements-clinical-trials-regulations-in-usa/ Fri, 28 Jun 2024 06:48:40 +0000 https://prorelixresearch.com/?p=10349 In the United States, The Food and Drug Administration (FDA) regulates and oversees clinical trials of food and dietary supplements and develops various regulations and guidelines for their use. The […]

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