Positively impacting lives by helping pharmaceutical, biotechnology and medical device companies to bring safe and effective treatments to market faster and more economically.
Pharmaceutical, biotech and medical device companies face complex challenges related to clinical data standardization, data integrity, and the regulatory submission demands in the development of new products.
With experience across a broad scope of therapeutic areas that include Oncology and Rare Diseases, Eliassen Group’s Biometrics and Data Solutions is a specialty contract research organization (CRO) with services that enable clients to ensure adherence to and compliance with data standards and integrity, and, in addition, expedite data analysis and output reporting for clinical trials (phases I-IV).
The team delivers expertise and services encompassing:
The Eliassen Biometrics and Data Solutions group provides scalable solutions with the flexibility to serve as a functional service provider, on a consulting basis and/or with staff augmentation.
Our team is dedicated to the long-term support of analyses required for many decision points throughout the lifecycle of drug development.
Our tenured subject matter experts bring extraordinary technical expertise and exceptional product knowledge spanning support of over 30 major submissions in multiple therapeutic areas and indications over the last 10 years.
Here is why Eliassen's Biometrics and Data Solutions team delivers unparalleled value to the pharmaceutical, biotechnology and medical device industries:
With over 300 fully engaged biostatistics and statistical programming professionals,
along with thousands more in our proprietary database, we can quickly ramp up to meet a wide range of demand requirements.
Deep expertise in all major therapeutic areas
and with direct submissions experience.
An attractive stable work environment,
learning opportunities, and career growth result in low turnover rates which yield consistent and reliable results.
Our solutions-oriented strategic partners
facilitate streamlined communication.
We pay close attention to detail
and possess a high proficiency in clinical study protocol design, collection methods, clinical end points, statistical models and methodologies.
We provide project management
and strong supervision over submission process and deliverables.
An award winning statistical programming team
with an average of more than 7 years of clinical development experience, directed by industry leaders with over 17 years of statistical /data management experience in the clinical development realm.
We provide timely, high quality “fit for purpose” deliverables
supporting clinical trial and submissions reporting.
Our flexible solutions enable you to contract with us on an individual resource need or scale up to a dedicated functional service provider model.
Subject Matter Consulting
An example of the value we have delivered to our clients:
Eliassen Biometrics and Data Solutions was retained to support a difficult regulatory submission with an incredibly short timeline (in only 75 days). The pharmaceutical company needed to file a critical submission with their clinical data which also required integration of data from several sources outside of their responsibility. Adding to the complexity of the project, the available data had multiple integrity issues, was not captured per the industry accepted standards and the scope of work was not clearly defined.
Eliassen Biometrics and Data Solutions assembled a team of programmers and a statistician who were experienced in submissions and dealing with difficult to manage data. A plan was developed to work with the existing data and once agreed upon, was executed.