Join CRS at the 2023 Government Biotechnology Innovation Summit

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.

PISA 2023 Attendees

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:
  • Statisticians or data scientists working in the field of pharmaceutical and health science, finance, insurance, machine learning, and artificial intelligence
  • Statistical researchers in an academic institute, but interested in industrial application
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“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”

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 Event
CRS Taam and Dr. Cramer's Presentation

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 Event

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.

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Adhering to and Preparing for Changing Clinical Requirements Around the Globe

A talk by Jon Ingi Bergsteinsson M.Sc., Matt Wagener and Alethea Wieland
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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.


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.

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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.

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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.

CMU Panel Discussion

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.

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