Clinical Services

We help the sponsor in defining the best investigation design according to parameters such as drug safety, study feasibility, best approval strategies, validity, science interest, and of course the investment profitability.

We apply intelligence and creativity to develop a global strategy to save resources when implementing the medicine in the major markets possible, considering that a good global planning avoids duplication of effort at the same time that simplifies the adaptation to international standards to the specifics regulations of each country.

We share the knowledge of our experts in the design of effective programs that allow the adaptation to each country regulation and a more efficient distribution of its products.

We offer medical writing services in designing and planning each trial as well as statistical analysis and data management.

ORus helps in the preparation of all documentation required for the development of a trial including the protocol, IB, informed consent, IMPD, etc., following standards accepted by the scientific and medical society that facilitate the process of submitting and obtaining approval from ethics committees and regulatory authorities.

We also contribute to the drafting of the final report, linked with the statistical analysis of the data, following the Guide ICH on the Structure and Content of Clinical Study Reports, which also facilitates the publication of the results as required by the Guide GCP of the ICH.

Project Management

We work with efficiency and effective in managing studies. Our professional team plans, organizes and manages complex clinical trials in global basis. The management team follows a program of continuous training in management skills and techniques for project managers. Thereby we can ensure the fulfillment of each phase of the project, reducing deviations and achieving the goals set which help to save costs. We are focused on quality and compliance with the deadlines of each study and especially of the budget. The main objective of the Project Manager of ORus is preserve customer satisfaction.

Site Selection

Through our Investigation department and our medical team we offer our support to our customers in selecting the best investigators for each study and ensure their commitment to the study.
We have complete and updated Sites and Investigators Database (SID) with which we can help each sponsor to select the best sites in Europe through our system of selection that ensures the service viability of each center (Pharmacy, Laboratory, Image Service, General Resources and Human Resources) according to the needs of the study.
Throughout our years of experience we have created links and ties with the investigators we have worked with. Many of them are our main prescribers and it allows us to achieve success in every study in which we participate.

Contract Negotiation

As a key factor in the development of any trial or study, we intermediate and provide legal advice in the negotiation of the contract between the Sponsor and all the vendors participating in the study, and help the client to adapt it to the local regulations.
In our goal of avoiding complications to the Sponsor, we take care of this activity identifying controversial clauses and anticipating the key aspects where we can achieve more flexibility from the parties and simplify the process.

Monitoring

The development and monitoring process of each study, shows different needs and ORus has a flexible structure with the capacity to adapt its procedures to these needs while maintaining quality in the whole process.
Our team of qualifies CRAs and thanks to the site and investigators network built up over the years of experience, we know how to optimize resources and improve investigators performance and adjust its effort to the study to guarantee the usefulness of each working hour.

Pharmaco-vigilance

We understand Pharmaco-vigilance as the process of monitoring the safety of medicines during the study and taking action to reduce the risks and increase the benefits of investigation medicinal product.
We provide a high quality PhV Service during each study by creating a specific planning for the safety system to be followed to each study adapted to the Good Pharmacovigilance Practice Guidelines included on the EU Legal Framework.

Quality check

We have qualified personnel and the system and the procedures required to review and complete quality check control of the studies that we have completed or studies that are being conducted by others.
This way we can ensure that the study and all documentation are in perfect conditions and ready for an occasional inspection from any regulatory authorities.

We have a wide applied experience on the intermediation process between the internal regulatory affairs department of the sponsor and the government agencies and competent authorities (Local, Autonomic, State and European) to reach the approval of the different studies and trials, simplifying the whole process and reducing the costs associated to this activity.

We work and count on with a wide net of sites and contacts in their ethics committees that allows us to guarantee minimum consumption of required resources to get the site EC approval of each study we became involved.

We can help on every activity necessary for data planning and management involved on the development of clinical trials: