Estimondo
Streamlining Statistical Programming for Clinical Research

With the growing expectations for fast and effective new drugs, biopharma companies and CROs are looking for efficient solutions and strategies to wade through the massive information for actionable insights. The challenges are more so in the areas of clinical research and biostatistics, which frequently sees new regulations to eliminate hindrances in clinical trials. Companies face difficulties in aligning with changing regulations, analyzing increasing data sets, and incorporating information from intercurrent events. A clinical research (CR) consulting company Estimondo understands that many CROs and clinical trial management organizations today require expert assistance in the areas of biostatistical planning, analysis, and reporting to achieve accurate results. To that end, the company offers comprehensive statistics and statistical programming services that augment the productivity of clinical researchers in their studies or experiments.

Estimondo was founded in 2017 by three veteran freelance biostatisticians and statistical programmers with more than 30 years of experience in CR. “We recognized the increasing challenges impeding the progress of several studies and sought to leverage our expertise and develop the best tools and strategies toward improved clinical trial management (CTM),” says Frank Freischläger, Founder and Head Operations, Business and Service Development, at Estimondo.

The company’s portfolio of offerings includes statistical writing for protocol development, SAPs, publications, and charters. The company also offers consulting services for trial designs, statistical engineering, and compliance. Estimondo separates itself in the market through its skillful and flexible teams that can help clients achieve the desired results quickly and cost-effectively.

Leveraging Metadata for Statistical Science

Estimondo implements the latest innovations in programming and technology to complement its statistical services. With its statistical programming environment for clinical studies (SPECS) service, the company collects all the relevant raw data and automatically develops accurate analysis reports using the metadata and tables, figures, and listings (TFL) shell versions. “We have significantly reduced hands-on statistical programming through our metadata-based approach that helps us provide clients with auto-generated scientific texts alongside statistical outputs,” expresses Freischläger.

Estimondo provides expert technical assistance in statistical programming, analysis, and reporting using an innovative metadata-based system

The company has developed a neural expert writing system (NEWS) by employing a unique metadata-driven approach. The system, coupled with SPECS’ capabilities, empowers clinical researchers with a new level of convenience in CR where 80 percent of biostatistics operations are automated. This program uses raw data from a client’s ongoing study to automatically generate an errorfree textual description of clinical study results, eliminating the need to conduct manual transcriptions. NEWS helps researchers save time to concentrate on more resource-intensive parts of the study and function more efficiently. “The systems we have developed allow for quick set-up, reliable execution, and fast turn-around times,” states Freischläger.

Estimondo’s unique customer engagement strategy helps the company better understand a client’s workflow protocols, which further bolsters collaboration. With this knowledge, it provides them with more particulars, namely automated programming specifications, and shell versions of TFLs, which not only look exactly like final versions but also are ready for production with approval. “While others start implementing these shell versions of TFLs, we are already done with it,” emphasizes Freischläger.

In a case study, Estimondo helped an interdisciplinary team working on an FDA-relevant Phase III study in psoriasis, which was already close to database lock when Estimondo came on board. “There were several biostatistical challenges, including complex hierarchical testing, multiple imputation, and tipping-point analysis,” adds Freischläger. By means of its metadata-based workflow, SPECS, and a flexible network of freelance professionals, Estimondo helped the client work with their partners, including CRO and its sponsors, and achieve fruitful results in short time.

Continuous Innovation in Biostatistical Science

Moving forward, Estimondo aims to expand its network of data science professionals and enhance their existing programming capabilities. “With more advanced machine learning and natural language processing technologies, Estimondo can structure and improve the quality of data within CROs and biopharmaceutical organizations,” says Freischläger. This helps the company not only expedite the statistical aspects of an ongoing study but also help produce more authentic content.

With the help of Dr. Ladislav Pecen, a Co-Founder of Estimondo and professor at Charles University in Prague, CZ, the company will revamp its estimands framework expertise and empower CROs with next-gen biostatistician capabilities. Estimondo’s comprehensive services truly possess the necessary attributes to help the world move toward becoming healthier, quickly.