Life Sciences

Solutions

• Clinical Trials

  René is a easy to use, easy to implement web-based software for clincial trials projects for bio-pharmaceutical laboratories, CROs and Research Centers. It allows to plan and manage multi-site projects, having precise registers of the progress and management indicators.

  René covers the administration of the project's life, the process management for documental production and the electronic management of the data (eCRF and eSubmission).

  It has a processes´ centered design that simplifies the regulatory compliance, allows process standardization (of documental management, recruiting, study agenda, etc), traceability in real time, and monitoring and auditing of everything that happens during the project.

• SAE Management

  The René technology for severe adverse events management (SAE) allows the regulatory compliance, reducing significantly the amount of paper, having more efficient operations, and having secured control and storage of the sensitive information.

  

  More information about René

• Document Management and Workflow

  The industry is becoming more and more regulated, intensive in the use of documents, with inter-organizational globalized processes, and with a demand of more efficiency and speed of execution each time.

  We build innovative technology to face up to this scenario.

  We are specialists in content management; our kbee.docs solution is a quality web service, easy to implement and easy to use for on-demand content management. It allows to comply with the HIPAA recommendations and with the norm 21 CFR part 11 from the FDA.

• Electronic Trial Master File (eTMF)

  You can save in a secure way, with efficient browsers, auditing registers, and with well-defined permits for each project's information, such as protocols, budgets, contracts, CRFs, technical documentation, financial information, progress reports, etc.

  Also contents such as SOPs, manuals, staff files, Marketing and communication material, training workshops, records, videos and seminars, etc.

  

  More information about kbee.docs

Services for bio-pharmaceutical Laboratories, CROs, Research Centers and Agencies

• René´s Implementation

René is a software that can be put to use immediately. It includes better practices from the industry in procedure templates, management indicators, forms, document templates, user's profiles, etc.

Our team of professional services has specific methodology, knowledge and experience in the bio-pharmaceutical industry. Particular requirements can be implemented with the minimum impact on your staff, in a reliable and fast way.

Consulting on Quality Certification ISO 9001:2000 for René users

Its strategy centered in processes and the Management indicators registers allow René to make the fulfillment of the ISO Quality norms easier.

Novamens is a company certified with ISO 9001:2000; we offer Consulting services for you organization to certify its processes with the ISO 9001:2000 Quality norm for Clinical Investigation based on René.

Training and Support

René includes a complete on-site training program for all user profiles, and personalized local service support during the execution of the Project/s which includes professionals from the product development team among the support staff.

The service includes server infrastructure and high quality connectivity ran by a team of engineers in operations and specialized security, with net monitoring, high availability and daily backup.

Projects of Document Management and Digitalization

kbee.docs Implementation services and digitalization for documental Management for safe archive and fulfillment of the regulatory ANMAT norms, norm 21 CFR Part 11 of the FDA and HIPAA recommendations.

Your organization suffers a minimum impact and in a matter of hours or, at most, days it is fully operational, obtaining operation savings, security for your sensitive information, efficiency and regulatory fulfillment.