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REMS Logic Model: Framework to link program design with assessment

Blogs, Pharmacovigilance, Regulatory / By

Risk Evaluation and Mitigation Strategies (REMS) helps the FDA in ensuring that the benefits of a drug outweigh its risks. These strategies are particularly important for medications with significant safety concerns and require a well-structured approach to both design and assessment. The FDA’s guidance on the Risk Evaluation and Mitigation Strategy (REMS) logic model presents …

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Machine Learning and Simulations for Clinical Trials

Blogs, Clinical Regulatory / By

clinical trial simulation Artificial Intelligence (AI) entails the use of computer techniques that make it possible for machines to undertake activities such as perception, reasoning, learning, and decision-making. New AI forms are being developed owing to progress in technology which has fueled developments in sectors such as facial recognition, finance strategy, autonomous cars etc. The …

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The Impact of Interactive Safety Graphics in Clinical Settings

Blogs, Clinical Regulatory, Pharmacovigilance / By

The world of regulatory submissions is transforming where static documents and data tables are slowly giving way to a more dynamic approach – interactive safety graphics. Traditional methods of presenting this data have evolved significantly with the advent of interactive safety graphics. These dynamic tools are transforming the way submission content is reviewed, how clinical study reports …

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Comprehensive Framework for Effective Clinical Trial Dialogue

Blogs, Clinical Regulatory / By

The need for effective clinical trial dialogue is imperative to ensure clarity, consistency, and alignment with stakeholders. A comprehensive framework for effective clinical trial not only facilitates this but also helps in enhancing trial outcomes and decision-making. An estimand may be used when conducting health-related studies or interventions to help clarify how to interpret treatment …

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Accelerating Clinical Trials in the European Union

Blogs, Clinical Regulatory / By

Accelerating Clinical Trials in the European Union (ACT EU) is an ambitious initiative to revolutionize clinical trials across Europe. This initiative brings together regulatory reforms, technological advancements, and collaborative processes to create a more efficient and impactful environment for clinical research. The ACT EU objective is to enable smarter clinical trials, through regulatory, technological and …

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DDReg Exhibits at the DIA Global Annual Meeting 2024

News and Events / By

The Drug Information Association (DIA) Global Annual Meeting 2024 was a premier gathering for professionals in the life sciences and healthcare industries. Hosted in San Diego, from June 16th to 20th, the conference served as a platform for the exchange of knowledge, insights, and innovations related to drug development, regulatory science, clinical trials, and healthcare …

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DDReg Exhibits at the BIO International Convention 2024

News and Events / By

The BIO International Convention in San Diego was an exciting and vibrant event, bringing in-depth insight to the latest developments within the biotech and pharmaceutical sectors.- and DDReg was thrilled to have been exhibiting there! The prestigious convention brought together leaders, innovators, and professionals from the biotech and pharmaceutical sectors and provided the perfect platform …

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Enhancing Global Drug Development through ICH M11

Blogs, Clinical Regulatory, Regulatory / By

The development of new drugs is a complex process involving clinical trials conducted across multiple countries. This can lead to challenges due to differing regulatory requirements and variations in how clinical trial protocols are formatted. The International Council for Harmonization (ICH) M11 Protocol Template, based on the ICH M11 guideline, aims to address this by …

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Leveraging Statistical Approaches in Drug Safety Analysis

Blogs, Clinical Regulatory, Pharmacovigilance / By

Drug safety in clinical trials is ensured through the application of statistical approaches. Adequate planning for safety analyses helps in identifying potential adverse events, evaluating their impact and ensuring that the benefits of a drug are greater than the risks associated with it. It starts from early stages i.e., with the designing of clinical trials …

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