CRS EVENTS
RECENT EVENTS
Carnegie Mellon University’s residency program for CMU Portugal at Project Olympus CMU
On April 8, 2025, it was our pleasure to participate in Carnegie Mellon University’s residency program for CMU Portugal at Project Olympus CMU. The purpose of this program is to provide opportunities for teams from Portugal to receive guidance and inspiration from life science industry experts and entrepreneurs, pressure test their business plans and strategies, and make connections in the U.S. and Pittsburgh ecosystems. CRS’s Julie Cramer, PhD, shared insights into the US FDA’s regulatory pathways for drugs and medical devices and mentored teams 1:1. Thank you to the Project Olympus CMU organizers and Max Fedor for the invitation and for developing a great program for these entrepreneurs!
Pittsburgh Regional Science & Engineering Fair
Carnegie Science Center
One Allegheny Ave.
Pittsburgh, PA 15212
The 2025 Pittsburgh Regional Science & Engineering Fair (PRSEF) on April 1-2, 2025 invites middle and high school students to take on the challenge of designing, implementing, and communicating an original experiment while competing for cash prizes and scholarships. PRSEF is open to all students in grades 6–12 from the 21 counties within Western Pennsylvania and Garrett County, Maryland. The Science Fair has been a Pittsburgh tradition since 1940. It is also the third oldest science fair in the United States under the affiliation of Society for Science, which runs the Regeneron International Science & Engineering Fair (ISEF) and the Thermo Fisher Scientific Junior Innovators Challenge middle school competition.
Each year, students from nearly 100 schools participate in Pittsburgh Regional Science & Engineering Fair. Students spend the 12 months leading up to the Science Fair developing and executing a project by utilizing the scientific method.
Clinical Research Strategies was proud to be a co-sponsor of the 2025 PRSEF and part of the judging panel.
Clinical Research Strategies was five strong at the Pittsburgh Regional Science and Engineering Fair on Wednesday, April 2, 2025. Zackary Adam Cope, Sierra Wilson, Dulce Mariscal, Alexis (Duray) Jancosko, and Julie Cramer were amazed at the level of scientific method and passion brought to the fair by regional high school students. CRS was happy to award two young men with our Sponsor Award in Translational Science; one with a device for real-time cardiac monitoring, and the other with a robotic exoskeleton for rehabilitation. The future of science is bright!
MEDICA 2024
November 11-14, 2024
Düsseldorf, Germany
Alyssa Harris, Clinical Research Strategies Manager of Clinical and Regulatory Affairs, represented CRS at MEDICA – the world’s leading trade fair for medical technology & healthcare in Düsseldorf, Germany, from November 11-14, 2024, where medical industry experts from more than 70 countries showcased a wide range of innovative products and services. MEDICA also had an extensive program of first-class forums, conferences and special shows that, once again, made this the industry event of the year.
MEDTECH Conference 2024
October 15-17, 2024
Metro Toronto Convention Centre, Toronto
Join the world’s top MedTech executives at the leading medical technology event. The MedTech Conference will help you look ahead and create new possibilities. Featuring world-class speakers, a cross-cutting educational program, invaluable networking and next-level technology, this forum for transformational ideas is a can’t-miss event for the industry’s prominent and most promising companies.
Inaugural Government Biotechnology Innovation Summit
September 27-28, 2023
The Sunset Room
National Harbor, MD
CRS Clinical and Regulatory Affairs Scientist, Dr. Haley Fuller, presented “Translating Biotech from Concept to Clinic” discussing the strategies that CRS offers early- to mid-stage life science companies for traversing the clinical, regulatory, and quality landscape, while highlighting a few DoD- and DARPA-funded programs that CRS has helped strategize a path towards regulatory approval.
The Future Shines at the 2023 Pittsburgh Regional Science & Engineering Fair
Carnegie Science Center, March 29, 2023
The 84th Annual Pittsburgh Regional Science & Engineering Fair (PRSEF) invites middle and high school students to take on the challenge of designing, implementing, and communicating an original experiment while competing for cash prizes and scholarships. PRSEF is open to all students in grades 6–12 from the 21 counties within Western Pennsylvania and Garrett County, Maryland. The Science Fair has been a Pittsburgh tradition since 1940. It is also the third oldest science fair in the United States under the affiliation of Society for Science, which runs the Regeneron International Science & Engineering Fair (ISEF) and the Broadcom MASTERS middle school competition.
Clinical Research Strategies was a sponsor of the fair and awarded one student with an award for Excellence in Translational Science. CRS’ Julie Cramer acted as the sponsor judge for the high-school level and judged projects based on innovation, translational aspects, and the student’s ability to answer thought-provoking questions.
CRS’ Bharesh Chauhan served as an affiliate judge for the high school level and David Anderson served as a category judge for the middle school level.
CRS was impressed by the level of scientific excellence from these young minds and it strengthened our hope for the future of science innovation.
Clinical Research Strategies assisted in the organization of an industry-focused statistics conference in the Pittsburgh region. We believe this is a great start to what hopes to be an annual conference for years to come.
For the 2023 event, our very own Haley Fuller, PhD, presented in the Biostatistics in Healthcare Session. Pictured above (l-r) are CRS’ Julie Cramer, Haley Fuller, Sidney Lane, Alyssa Harris, and Parul Nisha.
Inaugural Pittsburgh Industrial Statisticians Association (PISA) 2023 Conference
May 15, 2023
This conference provides a platform to catch up with cutting-edge statistical techniques, share innovations, brainstorm, extend social networks, build up collaborations, and search for statistician jobs.
This inaugural event was for:
“Device Trial Regulations, Quality, and Data Management”
February 7, 2023
Alethea’s presentation provided an in-depth understanding of the complex regulatory requirements and guidelines, examine clinical data strategy and use of RWD in pre- and post-market studies, and offer best practices to operationalize regulatory mandates.
Part of the
14th Annual SCOPE Summit for Clinical OPS Executives
“Driving Innovation in Clinical Trials & Digital Health”
ROUNDTABLE:
Perspectives on the FDA Guidance for Clinical Decision Software
DATE: November 15, 2022
Clinical decision support (CDS) software is a challenging regulatory space. Should it be regulated as a device? And if it is a device, what does that mean for the software development and testing?
Device regulatory experts Alethea Wieland, President & COO of Clinical Research Strategies and Managing Expert at Advarra Consulting, and Advarra IRB Chairpersons Robert Romanchuk and Erin Odor provided an overview of the final FDA guidance, and conducted a roundtable discussion of case studies to help attendees better understand how the guidance and other device regulations might and might not apply.
Women in Bio-Pittsburgh: Product Lifecycle in Healthcare – Strategic Steps to Clinical and Regulatory Success
Not all innovators or companies have the same needs. It depends on the product and the stage of development. Do you have a medical device in search of the right regulatory strategy? A drug or biologic that needs regulatory-clinical trial lifecycle management? Maybe you don’t even know the next step to get your product into the hands of those who need it. During this event, Dr. Nisha and Dr. Cramer discussed clinical and regulatory strategies that apply to medical devices and drugs/biologics, with examples of how these strategies were implemented.
Women in Bio-Pittsburgh’s 10th Annual P.O.W.E.R. Event: “Sustainability in an Unstable World.”
It was a packed house for WIB-Pittsburgh’s signature P.O.W.E.R. event. One key takeaway was that sustainability is not just one person’s job in a company. It has to be woven into each role and every decision.
NOW ONLINE!
Adhering to and Preparing for Changing Clinical Requirements Around the Globe
A talk by Jon Ingi Bergsteinsson M.Sc., Matt Wagener and Alethea Wieland
NOW ON-DEMAND!
Tips for Accelerating Your Medical Device through the Product Lifecycle
Presented by Advarra Consulting
With Alethea Wieland, President & COO of CRS
Successfully advancing new drugs and life-saving therapies to market for emerging pharma and biotech organizations, involves complex challenges throughout the product development lifecycle. 75% of medical device companies fail and may incur up to $100B in adverse quality costs associated with correcting compliance and regulatory issues.
This webinar discusses key medical device lifecycle product development processes as well as recommends proven strategies for early stage biopharma companies to achieve successful outcomes.
registration required.
VIDEO AVAILABLE!
Regulatory Pathways to Clearance: Transitioning University Discoveries
School of Health and Rehabilitation Sciences Innovation Seminar Series at the University of Pittsburgh
Dr. Julie Cramer, Associate Director of Clinical and Regulatory Affairs of CRS
During this talk, Dr. Cramer provides a regulatory perspective on how to transition your device-based discoveries out of the University. She discusses topics such as how to define your medical device, differences between your device’s intended use and indication, types of device market approval applications/pathways, and Regulatory Pathway Assessments.
CLICKING IMAGE WILL OPEN A NEW BROWSER WINDOW
FREE ON-DEMAND WEBINAR!
Tips & Tricks for Customizing a Clinical Trials Program for your Medical Device, IVD, or Digital Therapeutic that Satisfies Regulators, Investors & Patients
with Alethea Wieland, Founder and President of Clinical Research Strategies, and presented by Greenlight Guru
Join clinical trial expert Alethea Wieland as she presents her most valuable tips and tricks to help clinical, regulatory, quality, and marketing teams develop a clinical trial program that fulfills global compliance requirements, meets the needs of patients in various regions around the world, and serves as an ongoing compendium of evidence generation.
Bridging the Gender Race Divide / Asian American Chamber of Commerce
Clinical Research Strategies’ very own Parul Nisha, PhD, spearheaded Pittsburgh’s Asian American Chamber of Commerce entrepreneurship event at Carnegie Mellon University on May 7, 2022.
May is Asian American Pacific Islander Heritage month. This event celebrated their heritage with a day-long program featuring an Entrepreneurship Keynote and Leadership Round Table with eminent local thought leaders, along with a panel discussion on diverse topics – Biotech, AI/Robotics, Cybersecurity, Finance, Music, Art and Media. The Biotech entrepreneurship panel featured Susan Catalano, PhD, Kanak Iyer, PhD, Hyagriv Simhan MD, MS, and CRS founder, Alethea Wieland.
The Biotech entrepreneurship panel featured Susan Catalano, PhD, Kanak Iyer, PhD, Hyagriv Simhan MD, MS, and CRS founder, Alethea Wieland.
Praul Nisha, PhD and Kanak Iyer, PhD organizers of the Pittsburgh inaugural event by the Asian American Chamber of Commerce, held at the Swartz Center for Entrepreneurship at Carnegie Mellon University are featured on KDKA news, May 7, 2022.