Managing Regulated Content Enterprise-Wide

Kythera content management platform shaves TMF reconciliation time by 40 percent

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Kythera is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel prescription products for the aesthetic medicine market. The company’s objective is to develop prescription products using an approach that relies on the scientific rigor of biotechnology to address unmet needs in a rapidly growing market. Kythera’s initial focus is on facial aesthetics — the market’s largest segment. The company’s drug for the reduction of submental fat is currently in late-stage clinical development.

SYSTEM TO IMPROVE
Kythera sought a system to improve clinical document management and facilitate business processes for the development of its newest product candidate. The company had 26 studies already on file along with four active clinical studies, resulting in thousands of documents to share, manage and store. Kythera had been using a patchwork of different document repositories and systems for each functional area, including a file share system for TMF documents and a SharePoint-based system that was difficult to access and use for internal collaborators and external partners. Multiple versions of documents changed hands with no reliable document accountability. The resulting errors slowed study processes and added risk. Exchanging documents by couriers internationally only added to the inefficiency.

Kythera’s legacy system was also extremely difficult to manage and update. Modest internal IT resources meant Kythera required a turnkey system that integrated clinical, regulatory and medical affairs document management and didn’t require extra staff to implement and maintain. Renee Fate, Kythera’s senior manager of document management, already familiar with cloud technology knew that a multitenant cloud-based solution would be easier to update and maintain remotely.

Preparing for rapid growth and facing increased volumes of content, Kythera needed to select a solution without delay. After evaluating vendor offerings Kythera decided to trial then implement Veeva Systems’ cloud-based Vault, an end-to-end regulated content management platform built for the global life sciences industry, supporting business-specific applications and connecting workstreams across clinical, regulatory and medical affairs. The new solution would also link with Kythera’s promotional materials management system.

“We looked for an enterprise-wide solution that could effectively serve diverse masters across the business — regulatory, CMC, clinical, sales and marketing, HR, finance and legal — with different requirements for user knowledge, compliance and security,” said Jeff Webster, Kythera’s COO. “Vault was the right solution for us, given its intuitive interface, its functionality across Mac and PC platforms, mobile access, its full complement of 21 CFR Part 11 compliant capabilities, and the security and backup features necessary for our most important asset: our content.”

Fate added, “As a growing company without an IT team, we needed a cloud environment. With Veeva, we have no servers to manage, updates are pushed out automatically — without any disruption to our teams, and our mobile workforce can access the system from anywhere in the globe, with any device.”

SINGLE SOURCE OF TRUTH
Kythera rolled out Vault eTMF to manage all of its trial documents and support global collaboration between sponsors, CROs, sites and investigators with its integrated Investigator Portal. The company is also leveraging Vault Quality Docs to establish a single source of truth for all quality documents, and Vault Med Comms to simplify the global coordination of medical communications.

According to Fate, “Over the years, I have always received the same feedback from users: ‘We want more visibility, with information available in real time.’ Veeva Vault delivered on all fronts and was validation-ready, which makes my life much easier. Feedback has been very positive.”

Kythera has established Vault eTMF as its central hub for exchanging documents with CROs, investigator sites and other clinical partners. Each exchange is tracked by Vault and available via real-time reports that provide visibility into trial status and TMF completeness. The resulting data also provides actionable insights that allow Kythera to proactively improve study processes.

Currently, Kythera has more than 100 Vault eTMF users with plans to expand further with each new study site. The new solution brings Kythera a wide range of advantages, including:

Improved Workflow – Vault delivers total electronic access to documents that were previously transmitted as email attachments or as paper copies via courier. For Kythera, this has improved workflows throughout the trial process. For example, protocols authored by the medical writer are now uploaded directly into Vault, automatically notifying the requisite six or seven reviewers. The reviewers can make comments simultaneously in real time, and then the editor can consolidate, obtain final approvals and publish to Vault, helping Kythera move more quickly and reduce cost.

Electronic Signature Capture – Kythera is now able to capture electronic signatures and is building new SOPs to take full advantage of this time-saving convenience. “Historically we collected many more signatures than the government requires, adding a lot of inefficiency to the process because everything gets stalled while we wait on those signatures,” noted Fate. Electronic signatures will prevent needless delays in creating submission ready documents.

Timely eTMF Reports – Vault eTMF allows Kythera to run a full range of standard and ad hoc reports, giving them a view into trial progress and enabling better management of the study. The company uses Vault’s expiry report to alert team members before documents expire. Manually tracking expiration dates, due dates and receipt confirmations takes an enormous amount of time. Everyone on the Kythera team is happy to have Vault automate that work. A site document report shows the study documents on file for site and a site initiation report shows the status of documents for that milestone.

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