eClinical

The importance of clinical data management is rapidly increasing in evolving drug development and clinical research world. Driven by the inherited knowledge in clinical development, we are an exceptional Clinical Research Technology Solutions and Services provider:

Consulting Services for your Clinical Development

Are you conducting different types of studies from Phase I to Phase II, III or IV and have an increasing need for different and complex technology solutions around the clinical trial process? The selection of these solutions is far beyond choosing a single study tool; it should be closely associated with your Clinical Development Roadmap and IT Strategy.

We are your trusted partner who will accelerate your overall clinical development.

Having the clinical business and technology knowledge, we will help you to define your IT and Governance Roadmap besides focusing on each trial’s needs and designating the perfect fit solution to assure consistency of your productivity and governance all over your studies.

We will provide you with value-added consulting services to secure your operational success and compliance:

IT Project Management

The success of clinical trials highly depends also on qualified and competent IT Project Managers. We have accomplished several complex projects in clinical development, with our team of domain expert IT Project Managers having a great experience in Vendor Selection, managing timelines and budgets effectively, communicating and engaging with the stakeholders in a result-oriented way.

Governance and Oversight Solutions
According to the Good Clinical Practice of EMA, ICH GCP E6 (R2), Pharmaceutical and Biotech companies are required to implement a more structured and comprehensive monitoring of their projects. This requires a set of processes, put in place by the sponsor and the CRO, with the aim of providing the sponsor with a constantly updated overview of the CRO’s performance in projects, timelines, quality and results. The objective is to ensure the sponsor a proper oversight over the studies.

At Arithmos, we developed a comprehensive approach for Clinical Trial Oversight Management, from requirements analysis to the technology selection and implementation of the solution. In collaboration with our strategic partners, we also provide complete support in the reorganisation of Quality Systems, using a risk-based approach.

Learn More About Clinical Trial Oversight and ICH GCP E6 (R2)

Computer System Validation and SOPs

Even though the technology solutions used for the study can be already validated by the provider, the validation exercise including the user acceptance tests and vendor audits needs to be conducted by the pharmaceutical company itself as well. As an extension of the validation exercise, you may need also to review your SOPs.

We will conduct the Validation Exercise on your behalf and run a SOP gap analysis to ensure all necessary procedures are in place and maintain your compliance.

 Learn More About CSV and SOPs

Book a FREE assessment

Contact us now for receiving further information and a free assessment. We will evaluate with you the best approach for your business processes.

Off-the-shelf EDC Platform for your clinical study

If you are looking for an off-the-shelf EDC Platform that is immediately available for study setup and GoLive, we offer you a set of solutions, including Symphony EDC. Symphony is the perfect fit EDC Solution boosting your clinical trial performance by rapid study deployment and cost-efficiency, suggested by us in case of constraints on specific customisation or limited budget.

Contact us now!

If you would like to learn more about our services or receive a free assessment, please fill out the form. We will get back to you as soon as possible.

Contact us now!

If you would like to learn more about our services or receive a free assessment, please fill out the form. We will get back to you as soon as possible.