Three kinds of team

Three kinds of team,and what each one gets.

The second study starts from the first.

The first study builds the model: forms, checks, terminology, the visit grammar of your therapeutic area. The next starts from it, not from a blank specification.

Your modelForms · checks · terminology · visits
Study 1Built once
Study 2Reuses it
Study 3Reuses it

Many sponsors, one way of representing a study.

Each study keeps its own access, blinding and audit trail. What is shared is the representation, so a team moving between clients is not relearning another vendor’s screens.

Sponsor AStudy 1
Sponsor BStudy 2
Sponsor CStudy 3
SharedOne representation of a study

A first trial without an enterprise program around it.

The same audit trail, signature binding and export path as a large sponsor, because there is one build of the platform. Setup is a review, not a vendor queue.

Tamper-evident audit trail same as a sponsor
Signature bound to the record 21 CFR 11.70
Regulatory export path ODM XML with the audit trail
The protocol drafts the build your team approves it

Why teams move

Three reasons,and the mechanism behind each.

01 · THE BUILD

The build stops being a project.

A protocol goes in and a draft study comes out, each part carrying its clause. What remains is review, the part only your team could do anyway.

02 · THE AMENDMENT

An amendment stops being a change order.

It is a diff against the model that states its own consequences: forms, windows, findings and sites touched, before anyone accepts it.

03 · THE EVIDENCE

The evidence is written while the work happens.

Who, when and which clause are recorded at the moment of the act. Preparing for a monitoring visit becomes a query, not a reconstruction.

A customer

In their words.

AccuraTrials brought enterprise EDC capabilities within reach for our organization. The platform’s compliance features and ease of use were critical for our research operations.
Ashwinraj KarthikeyanCEO, Phoenix-Aid

Tell us whatyour study looks like.

Thirty minutes on the real platform. Bring a protocol and we will model it live.

Or email us: jgui@accuratrials.com