CRS NEWS
NeuroDawn’s Product Y-3 for Injection has Completed the First Subject Enrollment in the US Phase I Clinical Trial
The Clinical Research Strategies team is proud to play a part in this successful study as we implemented the study in record time during the holiday season and handled international shipments for investigational products.
CRS Joins Central New York Biotech Accelerator (CNYBAC) Service Provider Network
Clinical Research Strategies is proud to be a member of the Central New York Biotech Accelerator (CNYBAC) Service Provider Network offering Regulatory/Compliance, Risk Management/Quality Systems, Startup Company Support, and University Support services.
CNYBAC is an off-campus accelerator serving for-profit pharmaceutical, biologic, and medical device startup companies who are actively commercializing a biotech-related product or service. CNYBAC is operated by SUNY Upstate Medical University – the region’s only academic medical center – and is located in close proximity to Syracuse universities and hospitals.
CRS IN THE MEDIA
“When FMVs Collide: Coming to Terms with Fair Market Value”
Applied Clinical Trials Online, January 19, 2024
Norman M. Goldfarb
With variation in costs between different stakeholders in clinical trials, there is often disagreement on fair market value. As one of several experts cited in this informative article, Alethea Wieland, CEO and founder of Clinical Research Strategies, weighs in on the conflation of cost and value in the clinical research industry.
“Altered Humans—How Biotech Is Changing Who We Are” — an Epoch Original Documentary
In this new documentary, director Shaista Justin probes the moral and ethical questions surrounding medical innovations and technologies, asking not only whether the science is plausible, but if it is even desirable. Does progress for the sake of progress really move the needle forward for us as a species, or are we merely unwitting victims of medical experimentation that shouldn’t be pursued in the first place?
Clinical Research Strategies President, CEO and Founder, Alethea Wieland, is featured with other industry experts as they weigh in on the future of health.
Leadership Pittsburgh’s LP XXXIX Cohort, Fall 2022
Clinical Research Strategies is proud of Parul Nisha joining the 58 individuals named to Leadership Pittsburgh Inc.’s LP XXXIX cohort, representing a diverse cross-section of our community at significant levels of influence. Leadership Pittsburgh Inc., the local independent nonprofit, is best known for serving as the region’s premier community leadership, identification, connection, and development organization. The 2022-2023 cohort is their 39th to take part in the flagship, highly selective program, which includes 10 months of curriculum focused around examining the region’s most pressing issues. The program kicked off on September 13 with a reception at the Duquesne Club, followed by an opening retreat the following week at the historic Summit Inn. Thereafter, the class will convene monthly for daylong sessions with the program wrapping up in June 2023.
Read the Pittsburgh Business Times article to learn more. (Subscription required.)
Read our Pittsburgh Business Times Spotlight.
Clinical Research Strategies is amongst the Pittsburgh Business Times List of Life Sciences Firms in the region, placing 34 in 2022. Thanks to a GREAT team!
CRS Ranks #34 in the 2023 Pittsburgh Business Times List of Life Sciences / Medical Device Companies
The region’s biotech ecosystem remains strong in Pittsburgh — fueled by the presence of UPMC, Highmark/Allegheny Health Network and fed by the University of Pittsburgh, Carnegie Mellon University, Duquesne University and other regional institutions — as is evidenced by the companies on the List of Life Sciences and Medical Device Firms in the Pittsburgh region.
CRS Team Members are Helping to Promote Careers, Leadership, and Entrepreneurship for All Women in the Life Sciences
March 2, 2023
The Women in BIO (WIB)-Pittsburgh chapter is working to support recognized and emerging women leaders in the biosciences industry of Western Pennsylvania, Eastern Ohio, and West Virginia. Their mission is to promote knowledge sharing among women, impact regional economic growth, and stimulate empowerment among women leaders.
CRS team members are doing their part to help WIB-Pittsburgh promote entrepreneurship, innovation, education, and mentorship among women across our region. Parul Nisha, Chapter Vice Chair, will be supporting new Chair, Joie Marhefka. Vonya Eisinger has joined the team as Communications Co-Vice Chair, and Alyssa Harris has joined as YWIB Communications Chair. They are part of a solid leadership team, and we are so grateful for all their hard work in making Pittsburgh a leading WIB hub!
Learn more about Women in Bio’s Pittsburgh Chapter.
Women in Medtech: Alethea Wieland, President, COO and Founder of Clinical Research Strategies
October 3, 2022
In October 2022, Medical Design & Outsourcing acknowledged some of the women executives providing medtech industry leadership. Their editorial team highlighted female executives who are running some of the industry’s biggest companies and startups. Read the profile on Clinical Research Strategies founder, Alethea Wieland, as she discusses what drew her to the industry, barriers women face in medtech, and what can be done to promote the greater participation of young women in the medtech industry today.
Read the Women in Medtech Profile.
CLINICAL RESEARCH STRATEGIES
An End-to-End Approach to Compliance in Life Sciences
Life Sciences Review, March 2021
“In the EU, while regulations are meant for ensuring patients’ safety by adding more conformance requirements, they have severely compromised the Life Sciences industry’s quest to push the boundaries of innovation,” says Alethea Wieland, the President and Founder of Clinical Research Strategies.
According to a study published by Deloitte, “Globalization, alliances and partnerships, heightened transparency expectations, increased emphasis on innovative technologies, and ever-evolving needs for existing and emerging customers are driving them to re-examine their approach to compliance.”
As such, identifying, analyzing, and mitigating compliance risks have evolved into a fundamental prerequisite for Life Sciences companies in developing an effective strategy to help future-proof their business. However, keeping up the innovation pace with this regulatory landscape will no longer be an easy task, especially for startups and mid-sized organizations.
Read the full article online at Life Sciences Review.
PRESS RELEASES
Andrea Cruz, PhD Joins Pittsburgh-Based Contract Research Organization, Clinical Research Strategies, LLC as Clinical and Regulatory Affairs Project Lead
Pittsburgh, PA – June 9, 2025
Dulce Mariscal, PhD Joins Pittsburgh-Based Contract Research Organization, Clinical Research Strategies, LLC as Clinical and Regulatory Affairs Project Lead
Pittsburgh, PA – March 3, 2025
Alexis (Duray) Jancosko, PhD Joins Pittsburgh-Based Contract Research Organization, Clinical Research Strategies, LLC as Clinical and Regulatory Affairs Project Lead
Pittsburgh, PA – December 2, 2024
Yuki Kinoshita Joins Pittsburgh-Based Contract Research Organization, Clinical Research Strategies, LLC as Clinical Research Associate
Pittsburgh, PA – March 19, 2024
Anna Carpio Joins Pittsburgh-Based Contract Research Organization, Clinical Research Strategies, LLC as Clinical Research Associate
Pittsburgh, PA – December 6, 2023
Sidney Lane, PhD, Joins Pittsburgh-Based Contract Research Organization, Clinical Research Strategies, LLC as Clinical and Regulatory Affairs Project Lead
Pittsburgh, PA – October 26, 2023
Samantha Krebs Joins Pittsburgh-Based Contract Research Organization, Clinical Research Strategies, LLC as Clinical Research Associate
Pittsburgh, PA – June 8, 2023
Haley Fuller, PhD Joins Pittsburgh-Based Contract Research Organization, Clinical Research Strategies, LLC as Clinical and Regulatory Affairs Scientist
Pittsburgh, PA – February 20, 2023
Kaysie Foust Joins Pittsburgh-Based Contract Research Organization, Clinical Research Strategies, LLC as Senior Clinical and Quality Specialist/Auditor
Pittsburgh, PA – January 12, 2023
Local Business Owner, Alethea Wieland, Named to National Small Business Association (NSBA) Leadership Council and Participant in the Small Business Technology Council (SBTC)
Pittsburgh, PA – April 18, 2022
Vonya Eisinger Joins Pittsburgh-Based Contract Research Organization, Clinical Research Strategies, LLC as Senior Clinical and Quality Specialist & Auditor
Pittsburgh, PA – December 23, 2021
Candice Brett, Joins Pittsburgh-Based Contract Research Organization, Clinical Research Strategies, LLC as Manager of Business Operations
Pittsburgh, PA – November 9, 2021
Julie Cramer, PhD, Joins Pittsburgh-Based Contract Research Organization, Clinical Research Strategies, LLC as Associate Director of Clinical and Regulatory Affairs
Pittsburgh, PA – November 2, 2021
Frank Falcione, EMBA, Joins Pittsburgh-Based Contract Research Organization, Clinical Research Strategies, LLC as Senior Executive Quality and Risk Management Consultant
Pittsburgh, PA – August 27, 2021
Alyssa Harris, MS, Joins Pittsburgh-area-based Contract Research Organization, Clinical Research Strategies, LLC, as Clinical and Regulatory Affairs Project Lead
Pittsburgh, PA – February 1, 2021