Ergomed’s Meticulous Risk-Based Quality Management Approach

As a pioneer in providing comprehensive support for your clinical research, Ergomed champions an innovative Risk-Based Quality Management (RBQM) approach. This forward-thinking strategy ensures the highest patient safety standards, regulatory compliance, and data reliability. Ergomed’s proactive approach to managing clinical trials tackles clinical research complexity head-on.

Early Phase Experts

As a full-service contract research organization, Southern Star Research has the knowledge, industry relationships and technical expertise to get your early-phase clinical trial up and running safely and efficiently.

With a broad range of experience delivering Phase 1 Healthy Volunteer, First in Human, First in Patient and Phase 2 trials, we know just how important it is for your asset to succeed in the early development lifecycle. Our experienced team will help you obtain high-quality data that will appeal to future investors, meet the requirements of international regulatory bodies such as the FDA, EMA, PMDA, and Health Canada, and prepare your product for larger Phase 3 and 4 studies, partnerships, licensing, and sale.

Whatever your clinical trial needs, we can provide a flexible, bespoke solution that will not only meet your regulatory requirements but also position your product for commercial success.

Bioforum’s Clinical Data Management team is fully committed to providing high-quality and reliable services using the industry’s leading technology designed for quality data capture.

More than just an electronic data collection tool, our robust clinical data management system combines an intuitive user interface, seamless online and offline data capture capabilities, and comprehensive data management for clinical trials in a single solution.

Zelta’s EDC has been used in more than 4,000 studies from startup to submission, across all phases, including over 500 phase 3c trials and 23 therapeutic areas.

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.

It’s about time.
Modern eConsent.
Solved.

Deliver complex eConsent experiences that participants will love. Drive compliance and retention with truly informed participants, using a system that is easy to configure and manage from site to subject.

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.