In Clinical trials, objectives, outcomes, evaluation, sponsors, efficacy, endpoints, analysis, etc., – all these matters. But you know what, SAFETY takes the front seat.

Webisode 1 of Bots automate Clinical Data Management

Safety events reporting and monitoring is always considered meticulous in every clinical trial as well in epidemiology studies. There are a bunch of regulatory-specific guidelines put forth by the controllers such as FDA, DCGI, EMA, PMDA, TGA, CDSCO etc.

Regulations toward safety reporting are rigid and deviations from it come with very less tolerance. This always remains a headache for the pharma companies conducting clinical trials. Usually a large investment of time and effort is made in reporting and filing the reports to regulators.

Data to these safety events eventually come from the sites conducting the clinical trials. When we refer to site, it usually denotes the physicians / investigators treating the subject in the clinical trial who are involved in the critical task of reporting.

Subject safety is an untold primary objective and this makes serious adverse event reporting even more critical in the progress of clinical trials. SAE/AESI also demands the timely reporting and follow-ups as defined in the study protocol. Given all these constraints, one need not depend extensively on human intervention. This provides scope for automation.

Though automation might complicate the process if not developed user friendly, we chose to take the brave step of automating the SAE Reporting. With the checks and balances, risks and criticality assessment, we were able to arrive at a hybrid solution which will accelerate the reporting process.

Key features of the system:

Image

Overview of the process:

Interfaces:

Interfaces

Electronic data capture (EDC)

Electronic Data Capture involves the system where the study is configured as per the protocol. All the eCRFs including the safety forms (Adverse Events, Serious Adverse Events, Adverse Events of Special Interest), Medical history and medications data are captured and will reside in EDC.

Automated reporting solution

Custom application developed to support the automated reporting of safety events to Pharmacovigilance team (PV).

Mailbox

Mailbox of the PV, investigators and monitors, used for receiving the safety reports generated by the automated reporting solution.

Process Flow:

Image

Let us know your take on handling SAE Reporting. Drop your thoughts / questions in the comments section. Catch you in our next webisode!