We are a hybrid full service CRO and SMO, with exceptional competences in clinical research management and monitoring. We have capabilities and resources that are useful at every stage of the project development lifecycle. We help our clients optimize the management of clinical trials to achieve exceptional quality assurance, operational efficiency and precise regulatory compliance.

Our adept Clinical Research Associates have vast experience in monitoring clinical trials. We recruit only the best and support them to offer their best. Our monitors / CRAs have in the past worked with some of the leading global CROs and biggest pharmaceutical companies in the world. They hence combine their local expertise and global experience to deliver high quality deliverables using the most effective, culturally sensitive approaches.

Depending on the clients’ needs, Our CRAs perform risk based monitoring, centralized/remote monitoring, targeted monitoring as well as the following the more traditional monitoring approaches.

We monitor studies in any phase (phase I- IV) and at any stage (site feasibility assessments to close out visits) ensuring audit readiness at all times.

Our project managers are solution focused. With a proven track record of successful operational delivery, we continue to prioritize operational efficiency, proactively managing risk, timelines and budgets to ensure smooth and successful outcomes all the time.

When you partner with us, anticipate open and frequent communication between our team and yours, to ensure that our processes are customized to your business priorities. With so much at stake, there is no room for blind assumptions, sweeping generalizations or cutting corners.

You can rest assured that your project will be managed to the highest quality, cost-effectively and in a manner that is compliant with ICH/GCP and other internationals standards of best practices.

Our SMO arm supports clinical research sites through the provision of a diverse range of study management services. We support the site/ principal investigator to set up, or improve already existent processes to meet specified project, sponsor or regulatory requirements. Our SMO arm assigns site management associates (SMA) or /and Clinical Research coordinators (CRC) to a site to help with:

• Drawing study budgets and negotiating clinical trial agreements,
• Ethics and regulatory submissions,
• Developing standard operating procedures,
• Drawing patient recruitment and retention strategies,
• Drawing and implementing of quality management plans,
• Preparing for monitoring, audit or inspection visits,
• Clinical supply chain and vendor management,
• ICF translations and any other research duties.

The SMO arm also works with medical institutions to establish clinical research departments, support novice researchers and build clinical research capabilities.

Out training department offers research specific training courses and general business skills training. Our training courses include:

• Good Clinical Practice (ICH/GCP) training
• Ethical and regulatory aspects of clinical research
• Introduction to the principles and practices of clinical research
• Introduction to Clinical Trials Monitoring
• Clinical Trials management essentials
• Project management for clinical research
• Data management for clinical trials
• Effective leadership skills for clinical research professionals
• Communication and interpersonal skills at work
• Building clinical research teams that deliver