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.

1. Defining your medical device
2. Intended use vs Indication
3. Types of device market approval applications/pathways
4. De-risking the process
6. Meeting with the regulators
7. Clinical evidence generation

Watch the Video Presentation


Innovation in Oncology Precision Medicine: Diagnostics and Therapeutics

Julie Cramer, PhD, MS
Associate Director of Clinical and Regulatory Affairs, Clinical Research Strategies

MAY 2022

DNA Helix with Cancer Cell


Insights into the Field of Ophthalmology in Precision Medicine

Bharesh K. Chauhan, D.Phil. (Oxon)
Clinical and Regulatory Affairs Scientist, Clinical Research Strategies

JUNE 2022

Eye Exam and DNA Helix


Overnight variation in tidal expiratory flow limitation in COPD patients and its correction: an observational study

J. McKenzie, P. Nisha, S. Cannon‑Bailey, C. Cain, M. Kissel, J. Stachel, C. Proscyk, R. Romano, B. Hardy and P. M. A. Calverley

CRS’ Director of Clinical and Regulatory Affairs, Parul Nisha, PhD, contributed to this publication regarding an Observational study with an innovative technology that abolishes tidal expiratory flow limitation in COPD patient population by dynamic auto-titrating EPAP on a breath-by-breath basis. Check out the article.

COPD Publication

“Extremely proud to be part of this Philips Sleep and Respiratory Care team (formerly) – Product Managers, Engineers, Clinical Researchers and Scientific Writers that worked together for this publication and the overall project. Very fortunate to have collaborated with Prof. Peter M. A. Calverley on this publication. A next-generation exciting innovative product to help the COPD patient population. This publication will always remain a special souvenir for my six years spent at Philips – SRC!” — Parul Nisha

Parul Nisha PhD


Development of Aptamer-based IVD and Digital App for SARS-CoV-2 Testing Under NIH RADx and NIBIB POCTRN Programs During Global Pandemic

Parul Nisha, PhD
Director of Clinical and Regulatory Affairs, Clinical Research Strategies

COVID-19 Test Case Study


Conducting Clinical Trials and Human Factor Studies During COVID-19 Pandemic for Novel, Non-Contact Mobile-Digital App, InteloMed TeleHealth Technology (ITT!), that Detects Respiratory and Pulse Rates through Android or iPhone Camera

Alyssa Harris, MS, Clinical And Regulatory Affairs Project Lead
Clinical Research Strategies

Doctor Holding SmartPhone


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.

Life Sciences Review Article

Read the full article online at Life Sciences Review.



Regulatory Science & Clinical Research: Where Do We Stand (And Where Are We Going)?

By Alethea Wieland — Clinical Leader, July 14, 2020

We have all these new nifty ways to conduct research, and the regulators are initiating new conversations about how we need to conduct research, but the guidelines and regulations we follow lag behind the digital transformation. This article shares some thoughts on the current state of regulatory science, by reflecting back on two prominent meetings. READ MORE

What’s Really Behind the CRA Shortage in Clinical Trials?
A Root Cause Analysis

By Alethea Wieland — Clinical Leader, March 8, 2020

The #1 and #2 complaints I hear consistently from peers and partners in life sciences companies are the inability to hold third-party partners and CROs accountable for quality performance and to have a consistent experienced team over the life of their clinical trial. The two are inextricably linked. READ MORE

RWE in Clinical Research:
Challenges, Opportunities, and 2 Case Studies to Move Us Forward (Part 2)

By Alethea Wieland — Clinical Leader, September 26, 2019

This is the second article in a two-part series addressing real-world evidence (RWE) for life sciences leaders who may be struggling to make sense of the rules. READ MORE

Real-World Evidence in Clinical Research:
We’re Not in Kansas Anymore (Part 1)

By Alethea Wieland — Clinical Leader, September 19, 2019

This is the first article in a two-part series addressing real-world evidence (RWE) for life sciences leaders who may be struggling to make sense of the rules. READ MORE

What is Taking So Long for Meaningful Interoperability in Clinical Research?

By Alethea Wieland — Clinical Leader, June 6, 2019

Countless digital technological advances, data warehouses, and hardware and software programs have made our jobs more repeatable, less erroneous, and faster. Yet, we still have not made significant progress on interoperability between disparate electronic systems. READ MORE


Every Sponsor’s Top 10 Checklist for Selecting a CRO

This Top 10 Checklist is a helpful starting point that can be further expanded as necessary to help Sponsors de-risk the objectives of conducting a successful clinical trial.

Selecting a CRO Doc

Lessons Learned from a Rescue Trial

A clinical trial rescue is perhaps one of the worst realities that prior decisions during the due diligence, proposal review, bid defense, and ultimate award to a CRO partner failed. What ultimately goes wrong?

CRS Lessons Learned Rescue Trial Doc


What Most Medical Device Companies Face and How to Succeed

A first-hand view of challenges, best practices, and winning factors garnered through extensive work with early stage medical device companies.

The “Essential Guide: What Most Medical Device Companies Face and How to Succeed” has been authored by expert Alethea Wieland, Founder and President of Clinical Research Strategies.

CRS Essential Guide Cover
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