* This is a contributed article. The IBTimes news staff was not involved in the creation of this article and this content does not necessarily represent the views of IBTimes. When you buy through links on our site, we may earn an affiliate commission. Here are our T&C. For licensing please click here.
Lab Testing
This photo taken on October 14, 2021 shows a researcher examining a sample collected by a funnel-shaped net nicknamed "the sock" from the sea, at Japanese marine-station network Jambio's laboratory in Shimoda, Shizuoka prefecture. CHARLY TRIBALLEAU/AFP via Getty Images

Life sciences companies serve a broad range of missions; some target new medications, leading the way in clinical trials, while others develop innovative cancer-fighting technologies or advanced lab testing capabilities. The possibilities are vast, but the compliance intricacies faced by the life science sector continue to increase in number and complexity, throwing new curveballs to companies that have historically focused on innovation.

Compliance and regulation and life sciences is a no-brainer; at the end of the day, the products developed by these companies go on to impact human lives, for better or for worse. However, as companies operate on an increasingly global scale, the regulatory bodies and compliance requirements can get challenging to follow, hindering innovation and the advancement of critical life-changing treatments, medicines, and more.

By changing the narrative from research and development operating in a silo, separated from compliance and regulation to one that harmoniously merges the two worlds, life science companies can move the needle with cutting-edge innovation while effortlessly following compliance requirements. It sounds easier said than done, but necessity is making it possible, and now it's about a change in mindset and approach.

Unifying Technology is needed to solve reactivity

As it's not uncommon to see siloed processes between the functions of compliance and innovation, siloed technology is a massive hurdle for these teams. Finding an out-of-the-box solution that tracks R&D, offers a project update mechanism, and ensures that all components of the project are in lockstep with compliance demands has felt impossible for many in the life sciences sector. Because the requirements of regulatory bodies and the complexity of the industry already create challenges to keeping track of everything, doing it all at once is almost impossible for human teams. It seems they need the help of a unifying technological solution that will turn development, quality and compliance into a one streamlined process rather than separate applications that do not inter-communicate.

In an interview conducted by Deloitte, only 47% of compliance leaders feel that their company is proactive in implementing regulatory change. That means that over half of life science companies are operating reactively, costing excessive amounts of time and money across projects. If a project is in its final stages and under review, missed compliance requirements can mean the end of the road for that project.

When you have to re-start a project that has been in development for years, it can have wide-ranging implications, as is frequently the case in this industry. Based on a recent report from the Ponemon Institute, the annual cost of non-compliance for businesses in 2018 was $14.8 million, a 45% increase since 2011. When a drug that took multiple years to develop gets hit by a compliance issue from the FDA, it will not only be delayed from the market entrance but also be required to satisfy the requirements and sometimes even pay a fine. The bottom line is that it's worth it for companies to invest now in their regulatory and compliance approaches; doing so will save time and money in the long run.

Tides are Changing

There is a huge need in the industry. In recent years, many solutions have entered the market, offering the technology as a way for life sciences companies to bring compliance into the center of what they do. Often SaaS-based, compliance solutions from companies like SecureFrame, Drata, Laika, and Sprinto provide streamlined compliance workflows across multiple regulatory bodies.

However, the market is still missing a wide array of full-stack solutions. It has become more apparent that compliance cannot be conducted in a silo. Instead, it must be an integral part of the R&D process from start to finish. With this holistic approach, Orcanos, an Israeli company, is changing the technology landscape available to companies through a proprietary solution that integrates research, design, quality, and compliance all in one place.

It's challenging to have a smooth product life cycle. Orcanos faces these challenges and makes it much more attainable for companies in the life sciences industry to monitor compliance and regulation requirements from the beginning, but it doesn't stop there. The platform also helps shorten development time through better application lifecycle management, risk management, document control, and automation. Researchers and product development teams are only as good as the tools they can access, and today, technology is a tool.

Orcanos has a proven track record of successfully supporting clients of all sizes, even massive companies such as GE Healthcare. The solution designed by Orcanos is robust, long-lasting, and brilliant. Driving innovation through its innovation, with Orcanos, companies can now focus on what they do best: developing the best products for consumers.

The Future is Bright (and More Efficient)

The time to centralize compliance in every life sciences endeavor is now. Yes, the complexities of regulatory bodies and compliance requirements can be challenging to navigate, but ultimately, they exist for the safety of the people served by the life sciences sector. With the right tools and technologies, such as the Orcanos platform, companies of all sizes can seamlessly add compliance to the forefront of every project. And in turn, the life sciences industry as a whole will operate more efficiently and effectively.