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,

Procedural
system

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

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)

Identification
and Pritiorize

Identification and Prioritization is the process of systematically recognizing key issues, opportunities, risks, or tasks and ranking them based on their urgency, impact, and strategic importance. This step is critical in resource allocation, decision-making, and achieving organizational goals efficiently.

Clinical Operation
Oversight

Clinical Operations Oversight refers to the strategic supervision and management of all activities related to the execution of clinical trials. This function ensures that trials are conducted in compliance with regulatory standards, ethical guidelines, and company protocols.

RB
QM

. Technolgies 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

Crafting detailed SOPs that provide clear, step-by-step instructions to ensure consistency and compliance in your processes.

Clinical Study
Report

Creating thorough and accurate CSRs that detail the methodology, results, and conclusions of clinical trials.

Regulatory
Submision

Preparing precise and compliant regulatory submission documents to meet the stringent requirements of regulatory bodies.

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:

Developing detailed project plans that outline objectives, timelines, resources, milestones, and metrics that matter.

Risk
Management:

Identifying potential risks and implementing strategies to mitigate them, ensuring the smooth progression of projects.

Resource Management:

Allocating and managing resources effectively to optimize productivity and efficiency.

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

• Conducting thorough research on relevant regulations such as CTR, Diversity Action Plans, and ICHE6R3.
• Providing clear and actionable interpretations to ensure compliance.
• Assisting with the implementation of regulatory requirements within your organization.

Change Strategy and Implementation:

• Tailored Solutions: Developing customized change management strategies that are aligned with your corporate cultural vision.
• Communications: Crafting effective communication plans to ensure all stakeholders are informed and engaged throughout the change process.

Collaborative
Consulting Network

We leverage a robust network of subject matter experts to enhance our service offerings andprovide 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

Global Logistics and Supply Chain Operations encompass the end-to-end management of the movement, storage, and distribution of goods, services, and information across international markets.

(CSV)
Lifecycle
Management

CSV Lifecycle Management refers to the structured process of planning, implementing, validating, maintaining, and retiring computer systems used in regulated environments, such as pharmaceuticals, biotechnology, and healthcare.

Clinical Safety & Pharmacovigilance

Clinical Trial Diversity

Biostatistics and Data Management

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



admin@ascendiaclinical.com

Send us a message

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AscendingTogether