nir-vana innovation network

The company started their activity in October 2007 as a clinical contract research organization (CRO). Their headquarters are based in León (Spain) and have offices in Madrid (Spain), Torino and Roma (Italy) and Lisbon (Portugal). The company provides outsourcing services for research and investigation (covering the whole process to introduce new medical devices and pharmacy products on the market) with drugs, medical devices, cosmetics and functional food, from regulatory consultancy, study design and medical writing, CTA and monitoring activities, data management and biostatistics, and marketing authorization application consultancy and support. The CRO also provides support with the pre-clinical activities development all over Europe.
It is worth highlighting all services related to the setting up of clinical trials, i.e. development and review of protocols for trials, preparation of documentation adapted to the local law, obtaining the necessary approvals by the IECs/IRBs (independent ethics committee / institutional review boards) and regulatory international to national authorities, the design and elaboration of case report forms, biostatistics and determination of the sample size, selection of the best sites and investigators, negotiation of site and investigators contract, and everything required to set up a study.
Other services equally relevant are those related to the development of the study including the monitoring and follow-up of the trial, the support on maintenance of the necessary documentation, selection visits, start up, follow up, audits and close out visits, and completion of the trial. In association with this services its included the medical writing and statistical analysis, as well as the data management of the files generated during the study with a dynamic or permanent storage service for the generated documentation, aimed at not only the documentation of the studies for which the sponsor is responsible but also the documentation of the sites, researchers and other CROs.
The organisation is also able to create a specific safety system to be followed in order to reduce the risks and increase the benefits of investigation medicinal products during the studies. These pharmacovigilance service includes the creation of a specific plan to be followed in each study that is adapted to the good pharmacovigilance practice guidelines under the EU legal framework. The company also offers an EU QPPV (qualified person for pharmacovigilance) and LRPV (local responsible person for pharmacovigilance) in the countries where they work: Spain, Italy and Portugal. For multi-country trials and studies, the companies would handle the project as a consortium.
The CROs is interested in building alliances for multi-country studies and exchange of opportunities so the company is looking for subcontracting, outsourcing and/or commercial agency agreements, with international companies interested in full range of outsourcing services to sponsors and other CROs abroad seeking alliances for multi-country trials.

Advantages & innovations

By conducting local clinical trials over more than 12 years, the company can offer a better local knowledge which contributes to the proper development of a global study, identifying what needs to be done in each region and the actors involved. The 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) for the approval of the different studies and trials. Having opened over 700 sites guarantees proper advice on the contract negotiation between the sponsor and all the vendors participating in the study. The outsourcing proposed accelerates and facilitates the final result of a global trial and the flexibility is a core value that allows to adapt the services to all client requirements. Experienced staff, GCP/ICH framework (good clinical practice / international council for harmonisation of technical requirements for pharmaceuticals for human use), specific and comprehensive quality system and standard operating procedures (SOPs) form the backbone of the quality work delivered.

Stage of development

Already on the market

Partner sought

Pharma industries, biotech companies, medical devices manufacturers, food industry and other CROs interested in developing Phase I to Phase IV clinical trials, medical devices, observational and food studies, are sought under subcontracting, outsourcing and/or commercial agency agreements, in order to build alliances for multi-country studies and exchange of opportunities acting, both CROs, as agents to represent other companies´ services.