Evaluation Of Risk-Benefit Balance, Double-blind Protocol
CLINICAL TRIAL CASE PROCESSING
The data produced from clinical trials is usually more thorough than that received through typical channels of spontaneous reporting. Similarly, the steps for follow-up are often far easier to take. Nevertheless, you will need to demonstrate consistently that your reporting process is adequately specified and resourced to the task.
THE CHALLENGE WITH DOUBLE BLIND TRIALS
The standard for clinical trials is to work to a double-blind protocol. Before engaging in expedited reporting, your team will need to understand how to properly, without compromising the integrity of the trial, un-blind the trial. Furthermore, personnel need to be competent when presenting data to the authorities so as to maintain the integrity of the trial.
Expedited reporting requirements mean your standard operating protocol (SOPs) must include the accurate grading of incidents within an acceptable timescale. Our team at Almond Pharma have the experience to advise on the grading process to account for the delivery of timely and accurate compliance. Their input is also critical when it comes to demonstrating your analysis of risk-benefit ratios.
CAN YOUR TRIAL CONTINUE OR NOT? As your trial makes progress, you will need to reveal the continual evaluation of risk-benefit balance. This evaluation is the determining and deciding factor for the trial. During these trials SAEs are reported and as far as the regulators are concerned, the responsibility for correct case processing of SAEs remains with your company.
We ensure that there are suitable Safety Data Exchange Agreements (SDEAs)in place which must be agreed and accepted prior to outsourcing this service.
EXPEDITED REPORTING TIMELINES
During any pre-marketing trial, your company requires your investigator to specify which events are considered serious and unexpected within your reporting. Your investigator must also make you aware of particular types of non-serious adverse events or laboratory findings. Serious Adverse events (SAEs) must be reported to the regulatory authorities within specified timelines. If the adverse reactions are classified as fatal or life-threatening they should be reported within 7 days, as non-fatal, non-life-threatening SUSARS are reported within 15 days.
WHY CHOOSE ALMOND PHARMA FOR YOUR CLINICAL TRIAL CASE PROCESSING?
Almond Pharma’s experienced consultants interpret the case reports within the necessary Pharmacovigilance legal framework. Your submissions to the regulators will always be on time and you will not need to worry about penalties stemming from non-compliance.