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Clinical Regulatory

Here you get all the information related to the clinical trials regulatory services, management, and clinical development.

Leveraging Statistical Approaches in Drug Safety Analysis

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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Center for Clinical Trial Innovation

Medical research is progressing rapidly to keep up with the increase in complex disease. This has highlighted the need for innovation in clinical trials that can be driven by enhanced communication and collaboration. Stakeholders such as clinicians, researchers, patients, etc. can accelerate the development of novel therapies in order to improve patient outcomes by enabling …

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Enhancing Clinical Trial Regulations for Advanced Therapy Medicinal Products

Advanced therapy medicinal products (ATMPs) including gene therapy medicinal products, somatic cell therapy medicinal products and tissue-engineered products, are at the cutting edge of innovation and offer a major hope for various diseases for which there are limited or no therapeutic options and therefore, have been a subject of considerable interest. Given the increase in …

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Designing Early-Phase Clinical Trials for Cell and Gene Therapy Products

Early-phase clinical trials for cell and gene therapy (CGT) products differ from those for other pharmaceuticals due to unique product features and previous clinical experiences, which have revealed substantial risks, including multi-organ failure, leukemia, and tumor development. Factors such as prolonged biological activity, immunogenicity, and invasive administration procedures contribute to these risks. The design of …

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Conducting Clinical Trials for Investigational Products in Brazil

Brazil is emerging as an attractive location for clinical research as it offers access to a range of patient demographics and medical facilities due to its diverse population and robust healthcare infrastructure. Conducting clinical trials for investigational products is a meticulous and highly regulated process, requiring sponsors to adhere to stringent guidelines. This ensures the …

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Essential Aspects of Labeling for Clinical Supplies and Investigational Products

With the expansion of clinical research and development, precise labeling of investigational products is not merely a formality but a critical aspect ensuring the safety, efficacy, and regulatory compliance of clinical trials. Pharmaceutical companies are obliged to follow an integrated approach in labeling considering all aspects of clinical study planning to promote multilingual and multicultural …

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Assessing COVID-19 Symptoms in Clinical Trials

The onset of the coronavirus, or COVID-19, created havoc across the globe since its emergence in December 2019 in Wuhan, China, and fast spreading potential. Though no longer considered a “public health emergency” (under section 319 of the Public Health Services Act), the virus and its new strains are still actively circulating. This requires rigorous …

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Development of CAR T Cell Products

Chimeric antigen receptor (CAR) T cell products refer to therapeutic human gene therapy products. They involve the genetic modification of T cell specificity which allows them to recognize a specific target antigen for therapeutic use.  CAR T cells are associated with many challenges related to their development, manufacturing, testing, and even clinical evaluation. Therefore, it …

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The Advancements of Gene Editing Technology for Safe and Effective Gene Therapy Products

The field of gene therapy has witnessed significant advancements with the development of genome editing technologies. These technologies allow scientists to break, modify, and edit specific genes in a DNA sequence-specific manner, opening up new possibilities for gene therapy. While traditional gene therapy involves the addition of new genes to human cells or tissue, genome …

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Easing Requirements for Minimal Risk Clinical Trials

Expediting clinical trials that post minimal risk is important to advance healthcare & drug development. In particular, easing the requirements for informed consent regarding trial participants- for minimal risk clinical trials- can help expedite the entire clinical development process and ultimately accelerate the overall regulatory approval process. Earlier the US FDA’s regulations allowed for exceptions …

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