GxP Quality Management System (QMS) Solutions

Audit Services (program and site level)
Procedural Document System (QMS)
Executive on Loan

Operations and Optimization Solutions (R&D and non-R&D)

Identification and prioritization of key initiatives and focused management
Clinical Operations Oversight
Risk Based Quality Management (RBQM)
eTechnolgies integration support (people and process integration)
Vendor identification, engagement and management
Inspection Readiness
Trial Master File
Clinical Trial Feasibility
Business Continuity‍

Technical and Medical Writing

Our team of skilled technical writers has extensive experience in developing a wide range of
technical documents, including but not limited to:

Standard Operating Procedures (SOPs):
Clinical Study Reports (CSRs):
Regulatory Submissions:
User Manuals and Guides:

Project Management

Our team of experienced project managers has a proven track record of overseeing complex
projects from inception to completion. We specialize in:

Strategic Project Planning:
Risk Management:
Resource Management:
Budget Management:
Quality Assurance:

Change Management & Organizational Culture

We understand that successful change management and a strong organizational culture are crucial
for the long-term success of any organization. Our comprehensive services are designed to help you
navigate regulatory requirements and implement effective change strategies that align with your corporate vision.  

Regulations Research, Interpretation, and Implementation:
Change Strategy and Implementation:

Collaborative Consulting Network

We leverage a robust network of subject matter experts to enhance our service offerings and
provide our clients with the highest quality solutions. We collaborate with our network to deliver
services in the following areas:  

Global Logistics and Supply Chain Operations
Computerized System Validation (CSV) Lifecycle Management
Clinical Safety & Pharmacovigilance
Clinical Trial Diversity
Biostatistics and Data Management

Our Process

01
Personalized Consultation

We begin with a comprehensive consultation to understand your unique challenges, goals, and requirements in the clinical trial process. Our team takes the time to learn about your organization’s needs, ensuring a clear alignment on objectives and identifying the key areas where our expertise can make the greatest impact.

02
Strategic Planning

Based on the insights gathered, we develop a tailored plan that addresses your specific needs—whether it’s refining management processes, enhancing hiring practices, or supporting patent filings.

03
Execute and Support

From managing daily processes to guiding you through complex regulatory requirements, we execute with precision and agility, adapting as needed to ensure your project stays on track and aligned with your goals.

Get in Touch

Reach out to our dedicated team for any inquiries, appointment scheduling, or support.

5873 Winterberry Place, Allentown, PA 18104

(484) 951 3791

admin@ascendiaclinical.com

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Ascendia Clinical delivers expert consulting solutions for the Biotechnology and Pharmaceutical industries, with a focus on integrity, collaboration, and results. Partner with us for tailored strategies that drive your success.

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