ProRelix Research https://prorelixresearch.com Clinical Research Organisation - 9001:2015 ISO Certified Company Tue, 12 Mar 2024 05:27:35 +0000 en-US hourly 1 https://wordpress.org/?v=5.5.14 https://prorelixresearch.com/wp-content/uploads/2017/08/favicon.png ProRelix Research https://prorelixresearch.com 32 32 Investigator Initiated Trial (IIT) and Proof of Concept Study: Collaborative Model in Industry-Acade … https://prorelixresearch.com/investigator-initiated-trial-iit-and-proof-of-concept-study-collaborative-model-in-industry-academia-partnerships/ Tue, 12 Mar 2024 05:00:05 +0000 https://prorelixresearch.com/?p=10171 Explore the dynamic synergy between industry and academia in groundbreaking medical research through Investigator Initiated Trials (IITs) and Proof of Concept Studies. Uncover the collaborative model shaping innovative partnerships, driving […]

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]]> Biosimilars and Their Growing Importance in Healthcare https://prorelixresearch.com/biosimilars-and-their-growing-importance-in-healthcare/ Fri, 01 Mar 2024 12:35:06 +0000 https://prorelixresearch.com/?p=10136 Biologicals products occupy a significant place in the treatment landscape of several autoimmune diseases and cancers and are most often the only choice of treatment and management of several diseases […]

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]]> The Role of Real-World Evidence (RWE) in Drug Development: ProRelix Research Insights https://prorelixresearch.com/the-role-of-real-world-evidence-rwe-in-drug-development-prorelix-research-insights/ Mon, 26 Feb 2024 05:21:49 +0000 https://prorelixresearch.com/?p=10042 The role of Real-World Evidence (RWE) in drug development helps in gaining a deep insight into how real-world data and experiences come together to shape impactful pharmaceutical solutions. Introduction to […]

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]]> Designing Effective Oncology Clinical Trial Protocols https://prorelixresearch.com/designing-effective-oncology-clinical-trial-protocols/ Tue, 20 Feb 2024 08:37:53 +0000 https://prorelixresearch.com/?p=10022 Crafting impactful oncology clinical trial protocols requires a strategic approach to ensure rigorous research, patient safety, and meaningful outcomes. Explore key considerations and best practices for designing effective protocols in […]

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]]> Clinical Trial Success: ProRelix Research’s Tips for Sponsors https://prorelixresearch.com/clinical-trial-success-prorelix-researchs-tips-for-sponsors/ Tue, 23 Jan 2024 12:11:52 +0000 https://prorelixresearch.com/?p=9956 Despite advancements in digitization and remote or decentralized trials, traditional clinical trials with a central site, in-person recruitment and monitoring, and paper-based or electronic regulatory submissions continue to remain critical […]

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]]> Clinical Data Standardization in Clinical Trials: FDA Compliance in Clinical Data Management https://prorelixresearch.com/clinical-data-standardization-in-clinical-trials-fda-compliance-in-clinical-data-management/ Thu, 28 Dec 2023 11:49:01 +0000 https://prorelixresearch.com/?p=9881 Considering the crucial role that the information generated from clinical trials play in the approval of new drugs, biological, and medical devices, it is only logical that the data garnered […]

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]]> EMA Pharmacovigilance Regulations Updates https://prorelixresearch.com/ema-pharmacovigilance-regulations-updates-new-post/ Thu, 14 Dec 2023 09:02:17 +0000 https://prorelixresearch.com/?p=9823 Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. The European Medicines Agency (EMA) coordinates the European […]

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]]> FDA Pharmacovigilance Regulations Update https://prorelixresearch.com/fda-pharmacovigilance-regulations-update/ Mon, 27 Nov 2023 08:48:46 +0000 https://prorelixresearch.com/?p=9770 The United States Food and Drug Administration (FDA) has strict regulations regarding pharmacovigilance activities that are a part of post-marketing studies for drugs and medical devices that are required as […]

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]]> US FDA Foreign Clinical Trial Data Requirements https://prorelixresearch.com/us-fda-foreign-clinical-trial-data-requirements/ Wed, 15 Nov 2023 07:08:33 +0000 https://prorelixresearch.com/?p=9730 The growing impetus for the conduct of clinical trials outside the United States for products and medical devices intended to be used in the US include multiple reasons such as […]

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]]> Post-Marketing Surveillance Strategies https://prorelixresearch.com/post-marketing-surveillance-strategies/ Thu, 02 Nov 2023 07:25:03 +0000 https://prorelixresearch.com/?p=9716 Although clinical trials provide useful information regarding the efficacy and safety of new drugs, biological products, and medical devices, the information captured through them is not all-encompassing. Limited patient populations, […]

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