2 Months Micro-accelerator on path to clinical trial

Program:

Path to Clinical trial

 

Objective:

To help startups to get through detailed process walkthrough of clinical study design & trial and extended support to get their product certified

 

Duration:

An 8 weeks curated program for entrepreneurs in Healthcare. Micro-accelerator will be run by OJAS MedTech, in collaboration with Mallaready HealthCity, Samahita research solutions (CRO) and selected guest regulatory experts.

 

Who should attend?

  • Startups in the healthcare domain, medtech startups
  • Entrepreneurs, innovators, with MVP ready & planning for a clinical study design & trial

 

 Program Structure:

The program takes in a small number of startups and pair them with a resident mentor to methodically work with them. The structure may vary depending on the context of your startup.

 

  • Bootcamp
  • Mentoring sessions by CRO & industry regulatory experts

 

 Program content outline:

  • Healthcare products – Challenges from Inception to market introduction
  • Insights to Clinical Research Evolution and Stages
  • Stakeholders in a Clinical Research setting
  • Clinical Research- Effect on Product life-cycle and marketability
  • Ethics in Clinical trials of Medical Devices, software solutions & IVDs – Lime light on the darker side of the Device market
  • Regulatory Affairs – an insight to Regulatory requirements of Medical Devices, IVDs and software solutions
  • Standardization of Healthcare Products: Path for ISO and CE Certifications
  • Healthcare product – Post marketing surveillance and Survival in the Market
  • Personalized sessions for each startups to get their product certified

 

Program Calendar:

  • Program is spread across two months and includes:
  • Bootcamp: Mutual introductions with the team, mentors & setting up the context
  • Mentoring sessions:
  • Bi-weekly sessions with industry regulatory mentors
  • Up to 90 minutes every alternate week
  • Agenda discussed in the context of your startup

 

What do you get post program?

  • Facilitated customer connects
  • Follow- on access to mentors, events & demo-days for a year

 

RESOURCE PERSONS

 

  1. Srivatsa G. S., Managing Director, Samahitha Research Solutions
  2. Chandrashekar K., HOD, Clinical Research, Malla Reddy Institute of Medical Sciences
  3. Pavan P., Co-Director, Omega Laboratories
  4. Gaurav Mathur., Director &Head, Regulatory affairs, IQVIA
  5. Seema Tharannum., BISEP Faculty Co-ordinator, CRDM
  6. Sathyavathi L.M., Associate Editor, Research Synonyms
  7. Pravin., HOD, Clinical Research,
  8. Hedgewar Rugnalaya, Aurangabad
  9. Sanjeev B Rai., Chief of Research, Father Muller Medical College, Mangalore
  10. Soujatya Mallick., CRA, Zydus Group
  11. Bhavya Shivalingaiah., HOD, Respiratory Medicine,
  12. Divya & Prabha K R., Asst. professor, PES University

 

*program fee of 5K or virtual incubation for 6 months (virtual incubatee gets access to all programs, micro accelerators, events, mentoring sessions at OJAS)