DDReg pharma

DELIVER BETTER DATA TO ENSURE FASTER APPROVAL
DDReg Pharma

Author name: development

Comprehensive Framework for Effective Clinical Trial Dialogue

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 […]

Comprehensive Framework for Effective Clinical Trial Dialogue Read More »

Accelerating Clinical Trials in the European Union

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

Accelerating Clinical Trials in the European Union Read More »

DDReg Exhibits at the DIA Global Annual Meeting 2024

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

DDReg Exhibits at the DIA Global Annual Meeting 2024 Read More »

DDReg Exhibits at the BIO International Convention 2024

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

DDReg Exhibits at the BIO International Convention 2024 Read More »

Enhancing Global Drug Development through ICH M11

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

Enhancing Global Drug Development through ICH M11 Read More »

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

Leveraging Statistical Approaches in Drug Safety Analysis Read More »

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

Center for Clinical Trial Innovation Read More »

Data Integrity for In Vivo BABE Studies

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,

Data Integrity for In Vivo BABE Studies Read More »

Redesigned Pre-Submission Meetings for ANDAs with the US FDA

Pre ANDA meetings facilitate pre-submission communications with the US FDA to discuss questions related to complex products and/or complicated drug development questions. These were introduced in GDUFA II. In the GDUFA III some pre submission meetings have been redesigned to support prospective applicants in obtaining feedback from the Agency regarding their complex generics or complicated

Redesigned Pre-Submission Meetings for ANDAs with the US FDA Read More »

Electronic Submissions for Investigational New Drug Safety Reports

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

Electronic Submissions for Investigational New Drug Safety Reports Read More »