Clinical Trials Series 1/6: Overview on Clinical Trials

6-part hybrid series designed to walk you through the process of clinical trials.

Work alongside clinical trial expert, Tala Harake, in small, cohort-based working sessions.

Limited to 10 seats per session with lunch provided.

Tickets

$10 Non-ULP Member

$0 ULP Member - ULP Members can find their promo code on the Community Portal.

March 31 - Clinical Trial Overview

The session will give a brief overview of clinical trials, key definitions, FDA guidance documents and regulations available for reference as related to medical devices.

Working session to discuss the classification of your device: 15-minutes, 1-on-1 time slots. Attendees will be able to sign up on the day of the event. 

April 28 - IRB Overview (Guest Speaker: Erica Heath)

Role of the IRB in study conduct, when do we need the IRB to review studies, categorize devices and additional IRB roles. 

Working session: 30-minutes Q&A, 15-minutes, 1-on-1 time slots. Attendees will be able to sign up on the day of the event. 

May 12 - Key Elements of the Study Protocol

An overview of key elements when creating a clinical study protocol. Review of example templates for a clinical protocol.

Working session to review mapped clinical protocols: 15-minutes, 1-on-1 time slots. Attendees will be able to sign up on the day of the event. 

May 26 - Informed Consent (Medical Devices)

An overview and discussion on the key elements of informed consent, and considerations for creating a consenting process for clinical studies.

Working session (Clinical Trial: Developing Documents) Study Documents

June 9 - Creating a Study Protocol and Consent

In-person only, working session.

June 23 - Best Practices on Interacting with FDA (Guest speaker: Allison Komiyama, PhD, RAC)

A brief discussion on interacting with the FDA and Pre-subs. The do's and don'ts when interacting with the FDA.

Working session: 20-minutes, Q&A

 

Event Speaker

Tala Harake Headshot

Tala Harake

Clinical Research Consultant
Vigilant Clinical Trials Consulting

Tala Harake started her medical device career at UC Irvine as an undergraduate researcher in an animal cardiac research laboratory. After completing her undergraduate studies in Biology and Mathematics, Tala went on to earn a graduate degree in Biochemistry. She then began her career at Masimo, where she headed their clinical research department. In this role, Tala supported regulatory submissions, marketing, and engineering. During her time at Masimo, Tala rapidly scaled up their clinical lab to accommodate her newly designed clinical studies. This directly enabled development and expansion of the company’s vast product line from proof of concept to validation. During her tenure, she established multiple chemistry laboratories that supported in vitro research efforts and allowed for the validation of product DFU procedures in compliance with new FDA requirements. In 2020, Tala departed Masimo to start her consulting company Vigilant Clinical Trials Consulting, LLC. Since starting VCTC, her clients have included medical device start-ups, university research centers and medical societies. Throughout her career, Tala has been driven by a passion for medical devices and an underlying desire to help get these incredible devices to market and into the hands of healthcare workers.

Event Details

Community Event

Thursday, March 31, 2022

01:00 PM - 02:00 PM

Location:

University Lab Partners

5270 California Ave Suite 300, Irvine, CA 92617

Limited to 10 seats per session with lunch provided.

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