Biometrics & Data Solutions

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:

Statistical Programming and Analyses

Biostatistics

CDISC Consulting and Data Standards

Health Economics and Outcomes Research

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

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:

1

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.

2

Deep expertise in all major therapeutic areas
and with direct submissions experience.

3

An attractive stable work environment,
learning opportunities, and career growth result in low turnover rates which yield consistent and reliable results.

4

Our solutions-oriented strategic partners
facilitate streamlined communication.

5

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.

6

We provide project management
and strong supervision over submission process and deliverables.

7

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.

8

We provide timely, high quality “fit for purpose” deliverables
supporting clinical trial and submissions reporting.

Engagement Models

Our flexible solutions enable you to contract with us on an individual resource need or scale up to a dedicated functional service provider model.

 

Functional Outsourcing

  • Dedicated staff is an extension of your functional lines.
  • Our core business of providing sourcing and staffing services allows the functional outsourcing business to leverage hiring and retention best practices.
  • We leverage your systems, SOPs and processes.
  • Staff work from Eliassen offices under management supervision and control.
  • This allows our team and yours to focus on core competencies.
  • Resource depth (programmers, statisticians, project leads, technical subject matter experts).
 

Staff Augmentation

  • Traditional staffing support for specified duration.
  • Availability to work on-site, remotely, or in-house in one of our facilities.
  • Superior recruiting team efficiently and accurately identifies appropriate talent.
  • Highly qualified individuals are attracted, qualified, hired and retained.
 

Subject Matter Consulting

  • In-house industry recognized expertise in CDISC Data Standards and Outcomes Research.
  • Customized objectives and deliverables to address your specific needs.
  • Process review, analysis, and recommendations for implementation.

An example of the value we have delivered to our clients:

Major Pharmaceutical Company

The
 Challenge

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.

The
 Solution

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.

The
 Result

  •   On time submission (in 75 days)
  •   Multiple country approvals
  •   Timely patient access to affordable expanded product

Our Services

Reporting (Tables, Listings and Graphs)

  • SAE Reconciliation
  • Clinical Study Reports
  • Blinded Data Reviews
  • Drug Safety Monitoring Board Data Reporting
  • Manuscripts, Publications, Posters Support
  • PK/PD Reporting
  • Legacy Data Conversion
  • Ad hoc Reporting (exploratory analysis, scientific commercial support, label changes)

Electronic Submission

  • FDA Rapid Response Reports
  • Regulatory Queries (world-wide)
  • Third party Data Reporting Validation
  • SAS Transport Files and Define.XML
  • Annotated CRFs
  • Study Reviewer Guide (Data attributes)
  • SDTM and Define Validation
  • eCTD (submission metadata)

Biostatistics

  • Trial Design and Protocol Development
  • Power Analysis and Sample Size Calculation
  • Randomization Schemes Generation and Management
  • Statistical Analysis Plan (SAP) and Shells Development
  • Integrated Regulatory Submissions of Statistical Sections
  • Independent Data Monitoring Committees (IDMC) Statistical Support
  • Ad-hoc Analysis and Publication (abstract, poster, manuscript) Support
  • Integration of data from EDC, IVR, Adverse Event
  • Due Diligence

CDISC Consulting and Data Standards

Download our Paper!

Organizational Solution

  • Guide Set up of Internal Standards Group
  • Standards Integration within Organization
  • SOP development assistance

Implementation of CDISC Standards

  • Customize CDISC to fit study safety and efficacy needs
  • Implement and customize standards for Genomics
  • Integrate genomics with clinical
  • SDTM, SHARE and PGx

Metadata Repository Services

  • Selection and POC of Metadata systems

Metadata Management

Development of Governance policies

Management of taxonomy and terminology

Loading and maintenance of CDISC and internal standards

Integration of metadata from disparate sources linking to produce desired lineage

  • Retrospective Database Studies
  • Adherence/Persistence Studies
  • Epidemiology
  • Comparative Effectiveness Research
  • Prospective Study Design
  • Patient Reported Outcomes
  • Cost/Utilization Analysis
  • Outcomes Research Programming
  • Program Evaluation
  • Publication Support

Database Experience

TruvenHumedica
MarketScan(R)Premier
Optum

Technology Platforms

SASOracle
TeradataUnix/Linux

Coding Schemes Experience

NDCCPT
HCPCSICD9/10
ATCOthers