Study Start-Up

Give your trials a head start that lasts

Orchestrated Study Start-Up speeds site activation and keeps sites engaged throughout the entire trial.

Site Selection, Activation, and Training

Orchestrated to engage sites throughout the entire study

Study start-up (SSU) is so much more than a one-time document management exercise. It’s a global, strategic operation  that can get new drugs approved faster – and it’s ripe for innovation – from Site Selection to Site Activation and Site Training.

Many SSU tech solutions deployed by sponsors don’t deliver the results promised because they add burden without benefits to clinical research sites. The result? Site staff simply avoid using them.

When that happens, document exchange and tracking falls back to paper, email and Excel formats – with CRAs holding the processes together. The tools that were supposed to solve a problem become part of the problem – and consume precious clinical trial budget.

Your one-stop shop for faster trials

  • Accelerate site selection
  • Reduce site activation timelines
  • Eliminate site frustrations
  • Reduce burden on study teams and give them complete oversight

Powerful Site Activation Workflow

Automate user activities and track start-up data in your system of record with bi-directional CTMS orchestration.

Create consistent start-up processes with global templates for use across all trials and enable study teams to set up even large trials in a day

Select templates from the Global Catalog to configure start-up activities for varying study requirements by therapeutic area or countries chosen

Guide study team and site users through document collection and other site-activation steps using action icons, task-based filters, and notifications

Prepare and track regulatory and health authority submissions, including amendments and resubmissions

Transfer approved country and site documents to your eTMF system of choice, including required metadata values

Cross-study dashboards on site activation, training, and engagement metrics, available at the study, country, and site levels

Study Start-Up in the Investigator Site Portal

Site Selection

Expedite site selection decisions with built-in workflows that automate CDA acceptance and increase survey responses

Site Activation

Get to first patient/first visit faster and eliminate site frustrations by automating processes and enabling oversight for study teams

Learning Management

Accelerate site training and reduce the burden with automated assignments, cross-trial credits, and comprehensive oversight

Submission Management

Create and manage site submission bundles, including relevant study modifications and amendments, in one place

  • Create submission packages for approving authorities in the same system where document collaboration is occurring
  • Create amendments to capture changes to a particular submission, such as a new site or consent status
  • Create resubmissions for failed initial submissions in a single view
  • View study modifications to manage all activities - search, filter, and attach documents and see associated submissions in a single view
  • View submissions to access of all bundles including document downloads and change document status within the bundle

Discover the Value of Study Start-Up Technology that Sites Want to Use

Eliminate paper

Eliminate paper/email-based manual processes

Ensure compliance

Ensure every study stakeholder knows what activities to complete by when

Get oversight

Get real-time oversight of start-up progress

Advance adoption

Advance robust site adoption with minimal training

Gain efficiencies

Gain efficiencies from vendor-agnostic integrations with CTMS, EDC, and eTMF

Speed activation

Speed site-activation timelines up to 50%

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