TECH OUTLOOKJune - 202019in a clinical trial, a company deals with 25 different vendors, relying on 25 helplines. Our integrated solution means one helpline, expediting issue resolution," adds Kamath.As a veteran in the clinical trials space, Vsoft also urges its clients (or sponsors of the trials) to streamline its vendor contracts. For example, while an EDC vendor might have a three-year agreement, an IVRS vendor might be on board for a five-year stint. In such scenarios, the "hand off" from one vendor to another leads to significant communication gaps. This is precisely why Vsoft acts as more than just a technology vendor, ensuring that efforts of a previous vendor are not "flushed down the drain" due to a change in personnel. "Clinfoware® ensures increased trial success rates and meets timeline challenges, especially during drug development for pandemic like COVID19," he says. Kamath cites an example of poor communication--between vendors--causing a clinical trial to endure a retrial. Vsoft provided the client with an IWRS (Interactive Web Response System), controlling their clinical supplies and ensuring proper treatment was given to the subject(s). However, the client relied on another vendor to generate random codes for the study. "The vendor was supposed to send the scratch codes to the clinical site, but that did not happen," he recalls. Since the study was of the double-blind variety, the site could not disclose the details of the treatment to the subject. However, the scratch codes were needed in the case of an emergency, to indicate if a subject had overdosed on the medication. Ultimately, the FDA inspected the site and asked for the scratch codes despite the absence of serious adverse events or death. Again, poor coordination meant the sponsor was forced to undergo a retrial. "After one year of the trial, and 18 months of submission and audit, the client was ordered to do a retrial. The problem could not be fixed due to the lack of integration between various systems," rues Kamath.The Flagship Product These use cases point to the fact that pharma firms need to adopt an integrated clinical trial management system with dashboard like in a car that supports sound data management, statistical programming, and most of all, streamlines communication between various vendors in a trial lifecycle.Vsoft's fully-integrated product--Clinfoware®, a web-based transactional system, aids clients to not only achieve higher clinical trial success rates but mitigate unique problems encountered during all phases of a trial. Due to Kamath's history of working on random code systems, labeling tools, and EDC apps, he had the wherewithal to build a "flexible system that is adaptable" He elaborates, "Due to my past experiences, I could build a system that integrates the random code and labelling systems with the documentation module and EDC, giving clients the ability to understand the patient demography and accelerate the process of enrollment." As a matter of fact, Kamath notes that modern technologies can be harnessed only through an integrated system. "You need AI and analytics to monitor data, a lot of which is entered by the patient themselves through eDiary. If all the systems are not in sync, this is impossible," he adds. Kamath has evidently succeeded in building a robust clinical trial management suite that can streamline adversity, reporting, history coding, and data management services--to monitor and supervise a subject in a manner that is crystal-clear to every stakeholder in the process.The future is evidently bright for Vsoft, a pioneer in the realm of replacing silo-based clinical trial systems with a fully integrated, interactive system. As Vsoft has already exhibited, this paradigm shift is essential for the pharma, biotech, and CRO industries to transition from traditional clinical trials to adaptive clinical trials--with the end goal to increase trial success rates and reduce the costs. "We have proven that you cannot take a piecemeal approach to a clinical study. Otherwise, you deal with 50 different vendors, lose control of the trial, and have a balance sheet full of negative numbers," emphasizes Kamath. Driving forward, Vsoft is laser-focused on its target audience located in US and India, and expansion from merely allopathic medicine, to herbal and alternative remedies. In recent years, patients have turned to veganism and intermittent fasting to counter diseases. However, Vsoft is incorporating a new module in its system that encourages clients to add routines to their clinical trial along with a healthier diet. As evidenced by Anderson Cancer Center, Yoga has proven to improve efficacy during oncology trials.On a closing note, Kamath has a message to Vsoft's potential clients, "Rather than spending on multiple vendors, give us a chance to streamline your entire clinical trial. We can do one trial for free and offer a number of related services for reasonable prices." Clinfoware® ensures increased trial success rates and meets timeline challenges, especially during drug development for pandemic like COVID19
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