Ergomed’s Risk-Based Clinical Monitoring and Source Data Verification Approach for Data Integrity

Ergomed ensures the highest data integrity and patient safety standards through our risk-based clinical monitoring and Source Data Verification (SDV) practices. SDV is a critical process in clinical trials that ensures the data collected are accurate, complete, and verifiable against the source documents. We compare data entered into case report forms or electronic data capture systems with the source data to confirm their accuracy and reliability.

Navigating drug safety in the era of innovation-driven medicine

The focus on drug safety and pharmacovigilance has never been more intense. Patient safety remains paramount throughout a product's lifecycle, even as sponsors and marketing authorization holders (MAHs) face increasing complexity in managing safety data. This complexity stems from huge volumes of data generated from scores of diverse sources, much of it rapidly expanding unstructured data. Innovation-driven medicine is a key factor. These dynamics are reshaping the landscape of drug safety, presenting both challenges and opportunities for innovation in pharmacovigilance practices.

In clinical research, data are everything. At inSeption Group, we understand the vital role data management plays in getting life-changing treatments to patients faster.

ProPharma has deep expertise across all signal detection and management activities, including validation, prioritization, and assessment using data from a wide range of sources that are relevant for signal detection for the individual product(s). We are also fully trained and experienced in the EudraVigilance Data Analysis System (EVDAS) functionality and can support MAHs to comply with their obligations for signal detection and management. We leverage our robust knowledge to select the most efficient and effective method(s) for each product that is compliant with legislative requirements.

Speed without shortcuts: AI in clinical development

Our vision is to develop AI solutions that enable faster delivery of new medicines to patients.

AI in Clinical Development is at the core of Parexel’s approach to accelerating first-time quality and milestone delivery through our strategic operating model, Parexel Precision Pathway. We’re committed to the development of innovative, high-value use cases for AI in clinical trials. AI empowers our people at critical decision points and our AI investments prioritize process optimizations that:

1. Simplify complex tasks to accelerate timelines
2. Apply insights with agility to enable better decision-making
3. Enhance data handling to drive first time quality through content generation and workflow automation.

Biostatistical services, including SAP development, statistical programming in SAS, analysis, submission-ready services and statistical reports are customized and designed specifically to meet your project requirements.

The Revvity Signals Software Risk-Based Monitoring Solution is the most effective way to leverage data-driven insights to optimize site performance while improving patient safety.

Neither traditional nor hybrid clinical trials can operate on rigid EDC systems.

They require flexible data collection systems that support protocol amendments without downtime and accept mobile data without hassle. As a cloud-native solution, TrialKit bends to accommodate mid-study changes. And as the first full-featured EDC platform available as a native mobile app, TrialKit flexes to meet the demands of traditional, hybrid/decentralized, and completely remote clinical trials.

Give your team the freedom to build, deploy, and manage their studies, their way—weeks faster than with rigid EDCs and for a fraction of the cost of the major players.