Marti Farm.Ltd

This year drug safety has become the top worldwide concern. With the peril of the coronavirus, causing distress in all areas of life, people are cautiously waiting for the vaccine. As clinical trials and drug safety remain vastly obscure to the general population, the fact they are at the publics' center of attention will affect regulation and the clinical trial process as a whole.

Additionally, the pandemic has disrupted manual processes, exposing an even greater need for process automation. It is imperative for industry leaders not only to accept but embrace this shift.
Adopting new technology and tools will help with efficient clinical lifecycles and limited access to expert talent.

Under the Magnifying Glass

As always, sponsors will require impeccable services from CROs for their clinical trials. However, this won't be enough. Performing at the highest standards, CROs will need to provide transparency and eliminate inconsistencies. Resource allocation and process standardization are increasingly crucial because repetitive manual processes give room to error and strain clinical trial staff's workload. The current situation has made it apparent that digital systems reduce time and travel expenses, document lifecycles, and above all, minimize human error. As such, there will be less and less understanding for repetitive manual processes. Accuracy and accountability are crucial qualities in our patient-centered industry. And the industry will focus on systems that can provide these conditions.

Single Source of Truth

Relying on accurate data throughout the clinical trial process has always been of prime importance. Streamlining and standardizing these processes on all levels has excellent advantages. For example, imagine collecting clean data through a standardized Electronic Data Capture (EDC) system, seamlessly transferring that data to experts who will, within their standardized system, facilitate adverse event coding and transfer the results back to the originating EDC system. Such a process genuinely helps clinical experts complete sound research quickly with minimal room for error. Final results are achieved faster with more accurate biostatistical analysis and clinical study report generation. The output is only as good as the ingredients.

When dealing with drug safety and clinical data, the databases will need to be a single source of truth so that pharmacovigilance, regulatory, monitoring, and clinical team can work efficiently without being distracted by cumbersome manual processes where mistakes stack with time.

The question for the future is: How much can we consolidate data collection while producing high-quality clinical results and submissions to health authorities?

Data and safety reporting should not be a burden for principal investigators and their teams. We should provide them with a smart infrastructure that supports research, from trial design to final reporting. By automating tasks, we will minimize errors and enable experts to apply their best judgment without the burden of second-guessing the data that they are working with.

Striving for a Team System

We are taking calculated steps by developing a centralized management system where sponsors can have one point of contact for the entire clinical trial process. Our GCP Dynamic Partnership, with our partners from Wemedoo AG, utilizes collective expertise and provides a better clinical efficacy and safety platform. The partnership delivers a flexible aggregated data solution that is custom-tailored to adapt to clinical trial protocols. Our approach introduces new standardized processes and tools, evaluates vendor abilities, and meets regulatory and legal requirements.

Since 2014, Marti Farm has been developing an intuitive, cloud-based safety monitoring solution – Sympto^®. We needed a single validated tool that meets all of our safety data processing requirements and enhances teamwork. Sympto^® integrates all necessary modules from Literature search to FDA, EMA, and ICSR submissions into one comprehensive, user-friendly platform. It even automates data collection through the Activity report module to streamline audits and reconciliation processes for our clients.

Our partners share the same philosophy with their clinical data system, Oomnia, which integrates Electronic Data Capture and Clinical Trial Management System functionalities into a single, accessible platform. It is a secure, collaborative SaaS solution that meets all the requirements for accurate and precise conduct of clinical trials. Oomnia's intuitive and user-friendly interface, unlimited data capture capabilities, and built-in flexibility can facilitate the conduct of any clinical trial, regardless of its size.

Being proud CDISC members, our partners at Wemedoo have implemented the industry's highest standards into their system, thus ensuring standardized, high-quality deliverables throughout the trial process.

Our joint set of services can accommodate any clinical trial from inception to the final report, regardless of its size and geographical disposition. Collectively, with our cutting-edge software solutions and top-level expert support, we make each clinical trial run smoothly.

We work for tomorrow, and tomorrow's industry will make it easier for participants, site personnel, and the clinical team to produce the most high-grade research. We believe the future of clinical trials will be about systems servicing experts and not the other way around.