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Accelerating Clinical Trials in the European Union

Blogs, Clinical Regulatory /

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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Enhancing Global Drug Development through ICH M11

Blogs, Clinical Regulatory, Regulatory /

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 /

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

Blogs, Clinical Regulatory /

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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Data Integrity for In Vivo BABE Studies

Blogs, Regulatory /

The pharmaceutical industry is evolving with technological advancements with a subsequent increase in regulatory scrutiny that emphasizes maintaining the accuracy, completeness, and reliability of data- it has become more critical than ever. Data integrity ensures that information is trustworthy, verifiable, and compliant with regulatory standards. It is essential for safeguarding patient well-being, supporting regulatory approvals,

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Electronic Submissions for Investigational New Drug Safety Reports

Blogs, Regulatory /

Regulatory agencies like the United States’ FDA are increasingly encouraging electronic submission of Investigational New Drug (IND) safety reports. Electronic submission has numerous advantages over traditional paper-based submissions such as efficiency, accuracy, accessibility, timeliness and standardization. IND clinical trial sponsors are required to submit the IND safety report of serious and unexpected suspected adverse reactions

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A Collaborative Approach Towards Integrating Artificial Intelligence in Medical Products

Blogs, Regulatory /

Imagine a world where medical care is not just about treatment but about prediction and prevention. This is what artificial intelligence (AI) in healthcare promises, while also supporting innovation. Regulatory agencies across the globe recognize that AI technology work through a complex series of various processes, highlighting the need for end-to-end management across the lifecycle

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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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Pharmacovigilance in New Zealand

Blogs, Pharmacovigilance /

Medsafe oversees pharmaceutical product regulation in New Zealand and operates under the Medicines Act 1981 which mandates sponsors to report substantial untoward effects of their medicines. The requirement for regulations are highlighted in the Guidelines on the Regulation of Therapeutic Products in New Zealand (GRTPNZ) which also has a Pharmacovigilance (PV) guidance document. This provides

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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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