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Development Safety Update Report DSUR

The drug safety solutions team has in-depth knowledge and broad experience in all sectors of pharmacovigilance. Our highly qualified PV experts, combined with integrated technology, ensure that the product meets the highest levels of agreement with both local and global pharmacovigilance commands. DSSL is well equipped to make your business more sustainable, guiding you through the complete PV process and pivoting to meet your developing requirements. Our team is prepared to handle large case volumes and operates globally, supporting clients throughout the product lifecycle. DSSL pharmacovigilance services are available standalone or integrated with global medical information and regulatory services.

At DSSL, our goal is to offer high-quality deliberate and operational services to various biotechnology and pharmaceutical businesses. We have delivered best-in-class services in the global pharmaceutical industry with our non-stop efforts and dedication. We have acquired a team of specialists who have the required experience in the pharmaceutical and biotechnology industry to meet our goal. Their skills extend to the field of pharmacovigilance, compliance, regulatory, and other technological developments in the sector of biologics and DSUR in clinical trials pharmaceuticals.

An Effective Strategy of Creating DSUR 

The primary objective of creating an effective development safety update report DSUR is to generate a comprehensive, considerate annual review and evaluation of related safety information composed during the reporting period related to a drug under investigation. Our procedure includes:

  • Assess whether the information obtained by the sponsor during the reporting period agrees with preceding knowledge of the investigational drug’s safety.
  • Relate new safety issues that could impact the protection of DSUR in clinical trial subjects.
  • Create a Summary of identified and potential risks.
  • Give an update on the situation of the clinical investigation, development program and study results.

Our focus is to create a concise DSUR and provide information to assure regulators that sponsors are sufficiently monitoring and evaluating the evolving safety profile of the investigational drug and in DSUR in clinical trials. We make sure to write all safety issues discovered during the reporting period should be considered in the manuscript of the DSUR. Our mission is to promote the health and safety of patients. We are focused on performing the highest quality of services during the product lifecycle development.

FAQS

When should the DSUR be submitted?

The DSUR submission should be made within 60 days from the DSUR data lock point. The data lock point of the DSUR creates on the date of the sponsor’s first authorization to direct a clinical trial in any country.

Does FDA accept DSUR?

The FDA will accept the DSUR to meet an IND application annual report requirement to endorse global harmonization.

What is a DSUR in clinical trials?

The DSUR includes drugs, biologicals, vaccines, and specific products combination. It is an autonomous document that is not just a data assembly but is analytical.