Professional Services

We can work with you to accelerate your clinical trials

Whether you’re looking to introduce standardization throughout your organization, embrace industry standards such as CDISC, generate submission deliverables, or simply want to build studies quickly, we can help.

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Our Team

Since 2000 we have engaged with customers to optimize their processes, help them adopt industry standards, provide software to enable better management of metadata, and provide training services. With our extensive experience, you’re in safe hands.

If you're looking for CDISC expertise, we're second to none

We have been members of the Clinical Data Interchange Standards Consortium (CDISC) since 2001 and actively contribute to the CDISC Operational Data Model (ODM) and Define-XML teams. More recently we became founding members of the CDISC XML Technology Governance team, overseeing the technical direction of CDISC standards. Many of the key features in CDISC models have been developed or advanced by Formedix and our contributions have been recognized by multiple awards over the years.

Our Services

Our expert team work with you to provide bespoke services tailored to your needs. Some common examples are described below.

CDISC standards expertise

We help you embark on your CDISC journey, ensuring your team fully understand the standards. We offer:

  • Online and on-site CDISC training courses
  • Support on aligning forms to CDASH
  • Assistance with an internal CDISC standards roll-out
  • Assistance with aligning existing internal standards with CDISC standards.
Conversion of data

Datasets can be rapidly converted to CDISC SDTM, ADaM, SEND and other formats.

Preparation of submission deliverables

We can assist you with the creation of submission deliverables such as Define-XML, Define-PDF, Annotated CRF, and Study Data Reviewers Guide.

Standards maintenance

We help you to keep up with the pace of regulatory change by ensuring your standards are aligned with ever-evolving external standards such as CDISC, NCI Controlled Terminology.

Migrating studies between EDC systems

We can easily migrate data and metadata to your chosen system.

Optimizing processes and introducing internal standards

We analyze business processes and help introduce efficiencies across your end-to-end clinical trials.

Study design and build

Let us rapidly build your eCRF and dataset designs. Leveraging our EDC integrations we can:

  • Show how eCRFs will look in your chosen EDC system
  • Automatically build the study in your chosen EDC system.

Want to know more?

We're ready to discuss your needs and help you achieve your goals.