Our team is trained with a sharp focus on quality so
that any information that enters the safety database
meets its end-target, i.e., the most accurate riskbenefit assessment of the client’s product. Our
robust scientific and technical expertise in reviewing
cases at the time of receipt and performing an initial
assessment ensures a high-quality standard of the
case, requiring reduced effort at subsequent stages of
case processing.
The team is trained to perform a review of ADR
forms for accuracy and completeness and perform
an initial assessment of key parameters such
as seriousness/expectedness, which is valuable
for identifying critical path activities such as
expedited reporting. This crucial process step also
ensures that missing or ambiguous information
is identified at the earliest leading to prompt
resolution by querying the reporter.
Soterius’ safety data systems are backed by expert professionals with an eye for detail. Our processes have built-in checks in the form of activity trackers, compliance monitoring, periodic reconciliations, quality review checklists and detailed process overviews in tabular and graphic formats for better understanding and easier execution.
Our SOPs have been designed such that they contain an overall process map, with regulatory specifics defined in annexures, so that the team can focus on the most relevant information. Soterius processes are flexible. We can either follow client-specific or Soterius-specific procedures and as required, the team can also create and follow client-specific procedural documents.
Soterius shall have well-integrated case processing
operations. The teams shall remain in touch for
collection of data and provision of associated
feedback.
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