A clinical-stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases, with an initial focus on serious, debilitating metabolic genetic diseases.

Founded in 2010, the company has rapidly built a diverse portfolio of product candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.

The Situation

The client was entering the global marketplace in January 2018 and had to provide pharmaceutical compliance training based on their Healthcare Compliance Manual for all employees.

The Process

TrainSmart provided project management, instructional design, technical writing, and eLearning development services to resolve the client’s need.

TrainSmart completed the following tasks:

  1. Reformatted the Healthcare Compliance Manual into an interactive pdf format.
  2. Working with the client, parsed the Manual into content for 11 eLearning modules.
  3. Developed GUI interface samples in accordance with the client’s Style Guide.
  4. Developed Proof-of-Concept that the client could evaluate and test on their LMS.
  5. Provided multiple professional voice samples to the client.
  6. Transformed the parsed content into:
    1. 11 page-turner versions of approved screen content only to meet early training requirement.
    2. 11 treatments that reflected approved screen content and script.
  7. Developed adaptive eLearning modules that were SCORM 1.2 compliant in Storyline 360.
  8. Executed quality review cycle for all scripts and e-modules that included Alpha and Beta versions.
  9. Delivered all modules within budget and on-time.

The client executed the following steps:

  1. Reviewed all scripts and provided feedback in an iterative process.
  2. Reviewed all e-modules and provided feedback in a controlled iterative process.
  3. Released the 11 page-turner e-modules to meet early training requirement.
  4. Released final versions within USA.


  1. All USA training requirements were met.
  2. TrainSmart customized multiple US-focused emodules to meet European and Latin American compliance issues.
  3. TrainSmart converted multiple US/EU/LTAM scripts to job-aids to support field operations.