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 Solutions

01

Process Development and Optimization

  • AI-enhanced GxP process system design and optimization (e.g. global harmonization, regional compliance alignment)
  • Automated EDMS system configuration and usage analytics
  • AI tools generate dynamic procedural documents aligned with evolving regulatory needs

02

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)
  • Data Integrity
  •  AI Evaluation

03

Executive 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)

01

Clinical Operations

  • Provide strategic AI-powered oversight of all clinical trial activities
  • Ensure compliance with regulatory standards, ethical guidelines, and internal protocols
  • Maintain trial integrity, subject safety, and operational efficiency throughout the study lifecycle

02

Enhanced Risk-Based Quality Management

  • As a strategic ally to our clients, Ascendia Clinical delivers risk-based quality management solutions that elevate trial performance and regulatory confidence. With deep expertise in protocol risk assessment, centralized monitoring, and data-driven oversight, they help sponsors proactively manage quality across global studies—reducing inefficiencies while protecting patient safety and data integrity.

03

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

Strategic Collaborations

01

Strategic Collaboration for Regulatory Compliance

  • Enhances internal quality, regulatory alignment, and review processes validation frameworks
  • Enables scalable documentation processes through AI-driven insights and automation
  • Built through close collaboration with experts in quality assurance and validation to align with regulatory expectations.

02

Trial Genasys

  • Joint effort with Trial Genasys to create intelligent, data-validated clinical study reports (CSRs)
  • Combines Trial Genasys’s AI platforms with expert-led oversight to ensure ICH E6 R3 compliance
  • Improves accuracy, traceability, and submission-readiness of clinical documents through continuous AI-supported quality checks

03

New Leaf Consulting

  • Simplifies regulatory submissions by automating formatting, consistency checks, and compliance mapping
  • Developed in partnership with Trial Genasys’s AI systems for rapid turnaround and global submission readiness
  • Promotes transparency and version control during review cycles, ensuring confidence across stakeholders

Project Management

01

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

02

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

03

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

Enterprise Change Management & Organizational Culture

01

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.

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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