Ascending
Together

Our services go beyond standard solutions—we are committed to building strong, collaborative relationships with our clients. By working closely with your team, we customize our approach to meet your specific needs, adapt to changing demands, and deliver results that move you forward with confidence. With Ascendia Clinical by your side, you gain a trusted partner dedicated to turning challenges into opportunities for success.

Our team brings a proactive approach, anticipating potential obstacles and offering solutions that are as innovative as they are effective. With a focus on precision and partnership, we ensure that your project not only stays on course but also reaches new levels of efficiency and impact.

GXP Quality Management System (QMS) Solutions

Audit Service

  • Internal and External Audits (e.g., Data Integrity assessments, GxP facility audits including central labs, IRBs, CROs, computer validation,software vendors, hosted services,

Process System(s)

  • GXP Process system establishment or improvement (e.g., globalization, FA harmonization, regional/local alignment, etc.)
  • EDMS system set-up and utilization consulting
  • Procedural document development

Execution on Loan

  • Strategic resource for high visibility initiatives
  • Management level SMEs with extensive experience within drug development

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

Operations Diagnostic

  • Systematically recognize key issues, opportunities, risks, or tasks impacting clinical operations
  • Prioritize based on urgency, impact, and strategic relevance to guide critical decision-making
  • Optimize resource allocation to achieve organizational goals efficiently and effectively

Clinical Operation(s) Oversight

  • Provide strategic supervision of all activities involved in the execution of clinical trials
  • Ensure compliance with regulatory standards, ethical guidelines, and internal protocols
  • Maintain trial integrity, subject safety, and operational efficiency throughout the study lifecycle

Risk-Based Quality Management

  • Implement integrated RBQM strategies supported by technology, people, and process alignment
  • Support vendor identification, engagement, and oversight to ensure quality across partners
  • Enhance inspection readiness, TMF quality, trial feasibility, and overall business continuity

Technical and Medical Writing

Medical and Clinical Authoring

  • Develop clear, step-by-step SOPs to ensure consistency across clinical and operational processes
  • Promote compliance with regulatory standards and internal quality expectations
  • Support training, audit readiness, and continuous process improvement

Clinical Study
Reports

  • Prepare comprehensive CSRs that clearly document trial methodology, data analysis, and outcomes
  • Ensure alignment with ICH E3 guidelines and regulatory submission requirements
  • Support transparency, scientific integrity, and successful product approvals

Regulatory Submission(s)

  • Prepare accurate, well-structured documents that meet global regulatory authority standards
  • Ensure compliance with with health authorities, international standards, best practices, and laws
  • Streamline the submission process to support successful clinical and marketing outcomes

Project Management

Strategic Project Planning

  • Design comprehensive project plans with clearly defined objectives, timelines, and deliverables
  • Align resources, budgets, and cross-functional teams to ensure execution efficiency
  • Establish key milestones and performance metrics to drive accountability and success

Risk
Management

  • Proactively identify potential risks across clinical and operational activities
  • Develop and implement mitigation strategies to minimize impact and ensure continuity
  • Monitor and adjust risk plans to support the smooth progression of projects and compliance

Resource Management

  • Allocate and optimize resources to maximize productivity across projects and teams
  • Monitor resource utilization to ensure efficient and cost-effective operations
  • Adjust planning dynamically to meet changing project demands and priorities

Enterprise Change Management & Org Culture

Implementation and Continuous Improvement

  • Establish structured processes to ensure smooth deployment and integration of solutions across operations.
  • Monitor performance metrics and gather stakeholder feedback to assess effectiveness and identify improvement areas.
  • Continuously refine strategies based on data-driven insights to enhance efficiency, quality, and long-term impact.

Build with Our 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.

Global Logistics and Supply Chain Operations

  • Manage end-to-end movement, storage, and distribution of goods and services across international markets
  • Coordinate cross-border logistics to ensure timely delivery and regulatory compliance
  • Optimize supply chain processes to enhance efficiency, reduce costs, and mitigate risks

CSV Lifecycle Management

  • Oversee the entire validation lifecycle of computerized systems, ensuring compliance with regulatory standards
  • Develop and execute validation plans, protocols, and reports to guarantee system integrity and reliability
  • Manage ongoing system monitoring, change control, and periodic reviews to maintain validated status

Clinical Safety & Pharmacovigilance

  • Monitor, evaluate, and report adverse events to ensure patient safety throughout clinical trials
  • Implement robust pharmacovigilance systems to comply with global regulatory requirements
  • Analyze safety data to identify risks and support timely decision-making for risk mitigation

Our Process

Step 1

We begin with a comprehensive consultation to understand your unique challenges, goals, and requirements in the clinical trial process.

Personalized Consultation

Strategic Planning

Step 2

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.

Step 3

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.

Execute and Support

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

LinkedIn

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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