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Clinical Regulatory

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

Enhancing Clinical Trial Regulations for Advanced Therapy Medicinal Products

Blogs, Clinical Regulatory, Regulatory /

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

Blogs, Clinical Regulatory, Regulatory /

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

Blogs, Clinical Regulatory /

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

Blogs, Clinical Regulatory, Regulatory /

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

Blogs, Clinical Regulatory, Regulatory /

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

Blogs, Clinical Regulatory, Regulatory /

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

Clinical Regulatory, Insights, Regulatory /

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

Blogs, Clinical Regulatory, Regulatory /

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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Streamlining Clinical Investigations for Medical Devices

Blogs, Clinical Regulatory, Medical Device, Regulatory /

Clinical investigations for medicinal devices are critical in order to advance healthcare and patient safety. Streamlining clinical investigations help accelerate the delivery of innovative solutions to patients, which ensures timely access to devices that would help diagnose and treat diseases. Simplifying regulatory processes, enhancing stakeholder engagement, and aligning with global practices fosters more rapid approvals.

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The Use of Item Response Theory in Clinical Outcome Assessments

Blogs, Clinical Regulatory, Regulatory /

Clinical outcome assessments (COAs) are a critical component of clinical trials and regulatory submissions for regulatory agencies like the US FDA. The US FDA defines a COA as a “measure that describes or reflects how a patient feels, functions, or survives”; COAs provide important information to the US FDA on the effectiveness of therapies so

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