Workflow to add a trial

The workflow for adding a trial into Life Sciences AI Agents includes a series of steps starting with uploading a protocol or synopsis, reviewing and updating certain data parameters as needed, generating the three trial plans, and then selecting and finalizing an operational plan for the trial.

The workflow steps are:

1. Upload a PDF or DOCX file with the trial protocol or synopsis. The maximum file size is 50 MB.

   Life Sciences AI Agents confirms that the file type is supported. If yes, the process automatically advances to step 2. If no, the process stops and does not continue.

2. Life Sciences AI Agents extracts (also called ingests) data in the protocol or synopsis.
3. Life Sciences AI Agents validates required elements in the protocol. If any required elements are missing, you must provide the missing information.
4. Confirm or correct any parameters in the protocol or synopsis, as needed, and then generate the trial plans.
   You can review the trial objectives, study design, population characteristics, assessment plan, and optional planning parameters. When you review the extracted protocol elements, you can define specific operational assumptions such as:

   • Which sites to leverage in which countries.
   • Expected milestone dates aside from the expected Project Start date.
   • Maximum budget.
   • Maximum study duration (where the study duration is defined from the Project Start date, enrollment duration, and so on).

   For more information on the protocol parameters and generating the trial plans, see Upload a trial protocol and Review the uploaded trial protocol and generate the trial plans.

5. After Life Sciences AI Agents generates the three trial plans, you can review the plans, make adjustments as needed, and view plan comparisons before you select a plan for your trial.

   You can review, adjust, and compare the trial plans as often as you like. Then, you can regenerate the plans as needed before selecting the best plan for your trial.

   For more information, see Review the AI-generated trial plans.

6. Adjust any of the trial plans as needed. You can edit the details and sites for a trial plan, download a trial plan, and rename a trial plan.

   For more information, see Adjust a single trial plan.

7. Compare and download the trial plans as needed.

   You can view one or compare two trial plans at a time to help you identify which objective is the best option for your trial. You can download any combination of trial plan comparison charts as you like to a CSV file.

   You can also view the enrollment duration, expected enrollment, or average grant per subject by country for one trial plan, or you can compare the enrollment duration, expected enrollment, or average grant per subject by country for two trial plans. You can download the details for each to a CSV file.

   For more information, see Compare and download trial plans.

8. After you review and make any necessary adjustments to the trial plans, you can select the best plan for your trial from the available options.

   For more information, see Select a trial plan.