Standards for eClinicial

Assero’s primary focus is to help you get the most out of standards, as part of the eClinical Vision. We work mainly with the CDISC standards but are also conversant with the standards for clinical research from HL7, as well as the regulatory impact of standards.

When we work with clients we use a consistent methodology, supported by a common sense approach that has an underlying desire to keep things simple. Working with all of the stakeholders within your organisation we will:

  1. Assess – Through interviews, workshops and discussions with stakeholders and ongoing review, we assess what needs to be achieved.
  2. Vision & Road Map – We then deliver a long-term vision for a standards implementation to support the eClincal environment, along with a detailed road-map of how to achieve that vision. What makes us different is that both the roadmap and the vision are developed with you in order to deliver the best solution for your organisation and not one that looks rather similar to the last one we wrote.
  3. Implementation – We can then help you implement the road map working in four main areas:
    • Content & Metadata – Ensuring that your content & metadata are of the highest quality
    • Technology – Assist in getting the right technology solution in place as part of the wider eClinical programme
    • People: Communications – Often forgotten but vital to success, communications needs to be addressed as part of any implementation
    • People: Training – Getting the training right so that it maximises opportunities for engagement and minimises disruption is where our expertise can help
    • Governance – Working with you to get the optimum standards governance in place that meets the needs of the organisation.

We pride ourselves on providing the best independent advice and work solely to achieve what is best for your organisation.