About Formedix

We are a leading supplier of clinical trial automation software and services

Based on the internationally recognized CDISC standards, our solutions are utilized by Pharmaceutical, Biotechnology and Outsourcing (CRO) organizations globally. We enable them to run their clinical trials and prepare regulatory submissions faster and smarter.

We pride ourselves on the time, cost and process efficiencies our solutions consistently bring across the clinical trial process.

Leverage our experience for your next submission.  CONTACT US

Our Credentials

Since 2001 we have been members of CDISC, and soon after joined the CDISC Operation Model (ODM) and CDISC Define-XML teams. More recently, we became founding members of the CDISC XML Technology Governance team that oversees the technical direction of CDISC standards. We've added some impressive awards to our collection for our contribution to the standards.

Our solutions are aligned to CDISC standards and are used to standardize study designs and create more efficient studies. We've worked with organizations to streamline their clinical trial processes since 2000 and have proven significant time and cost savings each time.

Organizations working with Formedix leverage our experience to prepare submissions to regulatory bodies such as the FDA, EMA and PMDA. With extensive experience of CDISC standards and regulatory submissions, our expert team are well placed to help and advise you on your next submission.

We're regularly involved in: 

  • Introducing standards and providing training
  • Designing and converting CDISC SDTM, ADaM and SEND datasets
  • Creation of submission deliverables such as Annotated CRFs, Define-XML and Define.PDF files
  • Creation of Study Data Reviewer's Guides, providing advice on reviewer's comments and questions.

Our History

Founded in 2000 by CEO Mark Wheeldon, Formedix opened offices in Burlington, MA and Glasgow, UK. We became one of the first CDISC members and developed our solutions based on the standards. We continue to help shape the standards today.

In 2004, our study design tool was launched, earning CDISC ODM certification in 2009. Noticing a need in the market, we added dataset design capability in 2008. We quickly attracted partnerships with the leading Electronic Data Capture (EDC) vendors to integrate with their solutions. Today we integrate with 7 of the market-leading EDC systems.

2013 saw us host the first of our free learning webinars, educating delegates on CDISC standards, implementation best practices, and ways to optimize clinical trial processes. These free learning webinars continue to attract a strong following in the industry.

In 2014 we launched Formedix On, an online collection of on demand services and eLearning courses. Serviced by our eCommerce site, Formedix On was the first of it's kind to enable pay as you go access to clinical trial services and training.

Latterly, Formedix On has grown into our flagship product, a new generation of clinical trial software that seamlessly combines products, services and training in one platform. Today the platform is utilized by Pharmaceutical, CRO and Biotechnology organizations globally.

Meet the Board

Mark Wheeldon, Formedix CEO

Mark Wheeldon

CEO and Founder

Mark founded Formedix in 2000. He is an active supporter of the Clinical Data Interchange Standards Consortium (CDISC), which Formedix has supported since inception and is still one of the longest standing members. He firmly believes that a more efficient end-to-end clinical trial process lies in the successful implementation of data standards and clinical trial automation technologies.


Gordon Eadie


Gordon is a Chartered Engineer with a focus on technology management and innovation, and has worked in areas such as corporate development and economic policy formulation.  Over the last fifteen years Gordon has taken active management and investment roles in a number of start-up and early stage companies, characterized by the application of innovative technologies in various sectors.

Colin Garvie, Chief Finance Officer at Formedix

Colin Garvie

Chief Finance Officer

Colin is a Chartered Accountant by profession. He currently provides management consultancy, non-executive director services and general business advice to various businesses through his own consultancy company, Square 1 Consultants. Colin is the acting CFO of Formedix and has been involved with the business for the last 9 years.