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INSTILL FISCAL DISCIPLINE AND REDUCE RISKS

in Your Clinical Development and Quality Programs

INSTILL FISCAL DISCIPLINE AND REDUCE RISKS

in Your Clinical Development and Quality Programs

“We should not allow it to be believed that all scientific progress can be reduced to mechanisms, machines, gearings, even though such machinery also has its beauty. Neither do I believe that the spirit of adventure runs any risk of disappearing in our world.”

— MARIE CURIE

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LIFE SCIENCES CONSULTING SERVICES

Owned and operated in the US, Clinical Research Strategies is a contract research organization and executive management consultancy for start-up and mid-size life sciences companies. Project-specific, fit-for-purpose, ad hoc consulting, and staffing your clinical trials is what we do best no matter where you are in your clinical development program.

PHARMACEUTICAL COMPANIES

Protect your proprietary information while complying with transparency regs

International public disclosure regulations require that trial documentation be published in the public domain upon market authorization. Ensuring that your drug dossier is sufficiently redacted to protect your proprietary information is a complex and tedious task.

Clinical Research Strategies can alleviate the burden of redacting your clinical study reports, protocols, and similar documents. Our experts understand what is considered proprietary and can effectively ensure that your information is adequately protected.

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WANT TO LEARN MORE?

Contact us today for a quote or capabilities presentation.

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Want to Participate in the Development of a Cough Monitoring Wearable Device?

C-mo Solutions is an innovative company that has developed a wearable cough monitor. The cough monitor provides information about a patient’s cough to a healthcare provider. C-mo is interested in understanding how well users are able to receive and carry through instructions about using the monitor.

You do not need to have a cough to participate in this study.

The device testing will take place in early 2025.

“Our mission is to improve your business’ performance and provide a successful clinical research development plan and strategy.”

We are with our clients for the long haul — the ups and downs — supported by resilience and pragmatism.

TOGETHER, WE CAN TRANSFORM THE CLINICAL DEVELOPMENT AND REGULATORY STRATEGY OF YOUR MEDICAL PRODUCT.

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WHAT CRS CLIENTS ARE SAYING

“CRS has invaluable insight into managing CROs for Sponsors, which includes their extensive experience in clinical research. They were able to help us detect what were discrepancies or unnecessary charges, and negotiate more favorable terms in our contract, ultimately saving us over more than a third of a million dollars.”

Sean McDonald | CEO and Serial Entrepreneur, Ocugenix

“I am extremely pleased with the exceptional services provided by CRS. Their expertise and guidance have been instrumental in navigating the complex landscape of medical device regulations and clinical trials.”

Ella Helgeman | Director, Regulatory Affairs and Quality Assurance, Nowwell AS

“CRS has provided critical guidance for helping us understand the FDA approval landscape, develop our strategy through their Regulatory Pathway Assessment, and then helping us every step of the way with the logistics of obtaining FDA approval.”

Anna Li | CEO and Founder, Korion Health

“Our experience with CRS has been exceptional. Their commitment to providing top-notch clinical research strategy and execution has helped us navigate the complexities of medical device clinical trials … With CRS, you’re not just getting a service provider – you’re gaining a partner committed to your success.”

John W. Cromwell, MD | CTO and Founder, Entac Medical Inc.

“CRS has been an integral partner since the IMPACT accelerator program launched, providing a combination of education sessions and mentorship to help early-stage biotech and medtech founders navigate the complex challenges involved with clinical trials.”

Richard Meiklejohn | Innovation Leader, M2D2

Let the CRS team help you manage and overcome complicated trial operations and burdensome regulatory pathways.

Contact us today to arrange a no-obligation phone consultation.

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CONTACT US TODAY!

THE LATEST FROM CLINICAL RESEARCH STRATEGIES

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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.

UPCOMING EVENT

MEDICA 2024 Düsseldorf, Germany November 11-14, 2024

MEDICA 2024

November 11-14, 2024, Düsseldorf, Germany

Alyssa Harris, Clinical Research Strategies Manager of Clinical and Regulatory Affairs, recently represented CRS at MEDICA – the world’s leading trade fair for medical technology & healthcare in Düsseldorf, Germany, 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.

RESOURCES

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The Intersection of Artificial Intelligence and Neuroscience

Anna Carpio – Clinical Research Associate, Clinical Research Strategies

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The Roles of Technology Companies and Large Corporations in the U.S. Health System

Jennifer Le, PharmD – Clinical and Regulatory Project Lead II, Clinical Research Strategies

CRS NEWS

Alexis Jancosko, PhD

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

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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.

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