Playbook

Accelerated Clinical Trials are made possible through a tested, transformative methodology.

Our process ensures flexibility and adaptability, empowering our people to perform to the highest level in even the most-complex trials.

An ideal partner from planning to submission.

Distill, de-risk, and optimize your trial strategy through our Accelerated Clinical Trial Solutions.

Our medical, clinical, regulatory, and biostatistical experts bring clinical trials directly to patients. Our team helps balance KOL strategy with patient prevalence data to craft site and recruiting strategies that optimize accessibility and inclusivity during the planning phase.

  • Our clinical site strategy optimizes KOL engagement and supports brick-and-mortar sites while expanding patient catchment areas with virtual site augmentation capabilities to bring trials to patients in their homes. 
  • Participant recruitment leverages traditional site networks and partnerships across communities and the industry to expand geographies and diversify catchments. 
  • Final protocols and manuals of operations incorporate best practices for successfully executing a multi-site strategy that seamlessly combines in-clinic, at-home, and virtual assessments.

We complement traditional clinical strategies that focus solely on brick and mortar sites — which remain crucial for patient access and engaging KOLs — by providing innovative site augmentation and satellite follow-up solutions. Hawthorne Effect helps:

  • Allow brick-and-mortar sites to optimize patient retention, reduce missed or out-of-window assessments and increase catchment areas by providing the option to bring follow-up directly to the patient in their home.
  • Augment traditional sites models by adding virtual sites to reach patients in all geographies, improve diversity and accelerate enrollment while still enabling in-person assessments.
  • Initiate fully distributed sites and decrease study budgets by supporting investigators, including KOLs and DOLs, with technology-enabled oversight and a trained network of Hawthorne Heroes.

Our four-phase plan combines the ACT™ platform with our network of Heroes and a robust playbook of adaptive processes to ensure efficiency from planning to execution.

  • Consultation: Sponsors, CROs, and all-hands teams align on study objectives, business goals, and timelines.
  • Preparation: Patient recruitment, equipment, Hawthorne Heroes, site initiation, and maintenance plans are compiled.
  • Implementation: The study begins with patient recruitment, screening, consent, and randomization. Then visits are executed in-window and with unparalleled data quality. 
  • Completion: Hawthorne Effect prepares you for regulatory submission with audit preparation, data lock, clinical reporting, and post-approval requirements as the study nears completion. 

See firsthand how our ACT™ platform can accelerate your trials.