RESOURCES
Real-World Evidence to Support the Registration of a New Osteoporosis Medicinal Product in Europe
DIA’s Therapeutic Innovation & Regulatory Science — February 10, 2024
Alethea Wieland, president of CRS, contributed to this unique real-world evidence (RWE) study for regulatory decision making with the European Medicines Agency (EMA). This case study demonstrates successful use of RWE to address a previously identified gap raised by the CHMP during the review of an earlier MAA, which led to the approval of abaloparatide in the European Union (EU) under the trade name Eladynos for the treatment of osteoporosis in the EU.
Geographic Risk Factors: A Case Study on Opioid Use Disorder (OUD)
Samantha Krebs
Clinical Research Associate, Clinical Research Strategies
OCTOBER 2023
Value-Based Healthcare in the United States
Alyssa Harris, MS
Clinical and Regulatory Affairs Project Lead II, Clinical Research Strategies
Jennifer Le, Pharm.D.
Clinical and Regulatory Affairs Project Lead, Clinical Research Strategies
NOVEMBER 2022
MEDICAL DEVICE 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 II, Clinical Research Strategies
PRECISION MEDICINE:
Innovation in Oncology Precision Medicine: Diagnostics and Therapeutics
Julie Cramer, PhD, MS
Associate Director of Clinical and Regulatory Affairs, Clinical Research Strategies
MAY 2022
PUBLISHED ARTICLES
Real-World Evidence to Support the Registration of a New Osteoporosis Medicinal Product in Europe
Colleen Davenport PhD, Patricia Gravel PhD, Yamei Wang PhD, Setareh A. Williams PhD, Alethea Wieland & Bruce Mitlak MD — DIA’s Therapeutic Innovation & Regulatory Science, February 10, 2024
Alethea Wieland, president of CRS, contributed to this unique real-world evidence (RWE) study for regulatory decision making with the European Medicines Agency (EMA). This case study demonstrates successful use of RWE to address a previously identified gap raised by the CHMP during the review of an earlier MAA, which led to the approval of abaloparatide in the European Union (EU) under the trade name Eladynos for the treatment of osteoporosis in the EU. READ MORE
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
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
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
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
DOWNLOADS
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.
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?
ESSENTIAL GUIDE
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.
