Arkivum: Future-Proof Data Management Solutions for the Pharma Industry

It was expected that the growing utilization of technologies in the pharmaceuticals and life sciences domain would bring forth innumerable stringent regulations to oversee their usage. Unlike any other development, increased adoption of e-clinical trials and digitization of data has put a grave focus on maintaining security and long-term accountability. For instance, a recent EU regulation mandates drug developers to preserve and archive data such as a clinical trial’s electronic trial master files (eTMF) for 25 years. Although data storage solution providers have always been present, they are often not equipped to guarantee the readability, integrity and portability of the data stored for long durations. Thus, these regulations have compelled them to look for reliable partners that can not only store data in a compliant manner but also ensure data integrity and usability in the future.

The entire undertaking of archiving and preserving data can reach fruition only if it can be leveraged later down the line in times of need, and that power lies in London-based Arkivum. As a specialist in data archiving and preservation, the company’s automated solution—developed by combining the best practices in the data storage sector—guarantees the long-term storage of clinical data without any corruption and readability issues. “Clients can rest assured that any content stored on our solution can be easily accessed at any moment of time by stakeholders, auditors and inspectors for appropriate assessments,” says Chris Sigley, the CEO of Arkivum.

The company has left no stone unturned in amalgamating this ease-of-use and reliability into its offerings. The SaaS solution can securely store a wide range of content from multiple sources without impairing data ownership. After contractually guaranteeing that the stored data will remain safe and readable, Arkivum applies preservation techniques such as file format conversions and data validations to ensure that it is stored in a format that can be read even after decades. Moreover, as the solution is hosted on multiple cloud platforms such as AWS, Azure and the like, clients can scale the storage requirements depending on the current need of their business. Arkivum’s investments in developing a robust quality management system also strengthen the company’s vision towards providing best-in-class long-term data management solutions.

Despite many service providers focusing on safety databases and pharmacovigilance, Arkivum’s solutions stand out of the crowd by their impeccable capability to preserve data while adhering to ever-changing regulations. Additionally, its escrow functionality allows clients to store data without a long-term commercial contract, thus giving them the freedom to determine the longevity of the partnership.

Clients can rest assured that any content stored on our solution can be easily accessed at any moment of time by stakeholders, auditors and inspectors for appropriate assessments

The combination of this functionality with effectiveness in data preservation fosters a culture of trust and assurance, leading to an enriching customer experience and long-term relationships with clients. Arkivum has also invested into developing quality management systems (QMS) and computer system validation (CSV) processes in accordance with GxP. “Our software and our services are underpinned by one of the most robust QMS and CSV systems in the industry,” adds Sigley.

Arkivum’s collaboration with a US-based clinical-stage biotechnology company sheds light on its ability to store eTMFs in a manner compliant with Good Clinical Practice (GCP). As per the guidelines, TMF data was being retained for a prolonged period, but the client had found that this raised such challenges as potential future data corruption, lack of accessibility for stakeholders, uncertain readability of storage formats, and more. To address these issues, the client partnered with Arkivum and drew assistance in storing the eTMFs in accordance with GCP, FDA and ALCOA+ principles. Before storing the data, Arkivum’s solution reviews the data quality and proactively resolves any issues within it. This ensures that no underlying issues could impact the readability and integrity of the stored eTMFs. Hence, with capabilities such as these, the client could achieve compliant status for years to come without any hassle.

Building on such successful collaborations, the company is on the path to rapid success. Having recently completed a fundraising process a little while ago, it has all the necessary tools to heighten its presence in the data archiving and preservation sector and cement its position as a market leader. In a similar vein, Arkivum is looking to expand in the US and other regions. Moreover, with regulations changing continuously, it is always looking to enhance its technology and user interface capabilities for an improved experience. “Understanding the need for data preservation, we are working on several initiatives to bring our enhanced solution to sectors such as higher education, research, corporate and heritage records across the globe,” concludes Chris Sigley.