How Roche Pharma Germany cut 3 weeks of manual dossier preparation down to one click

Introduction

Roche Pharma Germany, one of the world’s largest biotech companies, is a global leader in in-vitro diagnostics and a pioneer in targeted healthcare. With a history spanning over 125 years, Roche Pharma Germany is known for innovation, regulatory rigor, and a deep commitment to research-driven breakthroughs.

In Germany, the company’s Health Technology Assessment (HTA) department is critical to bringing new therapies to market. Facing increasingly complex regulatory demands—especially in the European Union—Roche Pharma Germany needed a way to efficiently manage massive HTA dossiers. These documents often span thousands of pages and must comply with exacting formats, structures, and citation standards. To tackle this challenge, Roche Pharma Germany turned to Citavi.

The challenge

HTA dossiers submitted for German market access follow a strictly regulated methodological framework, requiring structured outputs, RIS files, and thousands of pages of precisely formatted evidence with comprehensive references.

For Roche Pharma Germany, this meant managing vast amounts of data—often over 4,000 pages per dossier—while coordinating across internal teams and external vendors under strict confidentiality. But existing tools like EndNote lacked the server-based functionality and collaboration features needed, leading to duplication, inefficiencies, and a higher risk of regulatory noncompliance.

“The German HTA procedure of benefit assessment for all new drugs and new indications with all data used during the approval by EMA (European Medicines Agency) is strictly methodically regulated. There are given templates and special requirements for the data, structure, and output with RIS files and all attachments you cited with the numbered structure of the citations for each module of the benefit assessment dossier,” Dr. Anne-Eve Roske, MD, Roche Pharma Germany Pharma AG.

Without a centralized system, even small updates meant time-consuming changes across individual accounts. Maintaining consistent citation styles and knowledge structures was burdensome, especially given the volume of content and number of contributors.

The solution

To meet the demands of the HTA process, Roche Pharma Germany implemented Citavi’s database server version nearly a decade ago, hosted internally to ensure full data control and confidentiality. Citavi offered a scalable, collaborative solution tailored to Roche Pharma Germany’s dossier needs. The team created a master database structure that ensured consistency across all HTA projects, and every new dossier began with a copy of this standardized framework—complete with predefined categories and lists.

Custom fields and dropdowns were added to match specific HTA requirements, while Citavi’s flexibility allowed Roche Pharma Germany to develop proprietary add-ons that automated complex outputs. One of the most impactful innovations was an add-on that enabled one-click exports of RIS files, attachments, and structured citations for each module—replacing a process that had once taken three dedicated colleagues three weeks to complete.

Citavi’s server-based architecture also streamlined administration.

Citavi also became an essential tool for compiling dossier content. “That is a requirement of the of the assessment that we use the Word templates to fill in with the text and the references. And sometimes I use the knowledge terms to cite it. Tables, pictures, texts. . . It's a great tool. I would not want to miss it in the future. It's the easiest way to cite the knowledge terms,” said Dr. Roske.

With these capabilities, Citavi became a foundation for Roche Pharma Germany’s HTA success.

The results

Since adopting Citavi, Roche Pharma Germany has transformed the way it manages HTA dossiers. What once required weeks of manual work has been reduced to a streamlined, repeatable process. With over 60 projects and 3,000 references—plus more than 16,000 attached PDFs—Citavi enables Roche Pharma Germany to organize, access, and output data with speed and accuracy.

The ability to control updates centrally has improved consistency across teams, while secure, role-based access ensures compliance and confidentiality for both internal staff and external vendors. The automation of RIS file generation and structured citations has eliminated repetitive work and reduced errors. Research workflows have also improved significantly.