3. Research Services
In Meditep we are experts in the comprehensive management of research projects. We have a long
experience generating, developing, implementing and disseminating clinical studies. We have carried
out successfully differentiated and innovative research projects, from the first statement of doubt or
hypothesis to the final publication in seminars and international journals. And we can add years of
clinical activity and a close relationship with a wide range of professionals. As a result, in Meditep we
offer all the necessary services that your project requires to reach its goals.
4. “Meditep adds commercial value to your
scientific activity”
… + advantages? What else would you like
to get from Meditep?
In Meditep we understand the effort
necessary to carry out your research In Meditep we offer something else than
project, and the different knowledge technical research knowledge, something
areas that need to be covered for it to be else than the experience obtained by
successful. With Meditep, our working with a wide range of
customers' projects gain better professionals. What else do you need?
performance, a wider dissemination of We can get it!
results, more resources and greater
efficient management.
5.
6. The portfolio of services that Meditep offers to its customers include:
1. SCIENTIFIC SERVICES
This area includes services related to the knowledge of the scientific method together with clinical
knowledge and health care practice. Among others, it encompasses the following services:
1.1. Proposal for a Study Design Concept (SDC): objectives, resources and deadlines
1.2. SDC assessment by experts, either individually or within a scientific committee
1.3. Methodology adjusted to the objectives: design, statistics, publication plan…
1.4. Design of a Case Report Form, with a definition of variables
1.5. Scientific justification and assessment dossier based on present knowledge
1.6. Definition of the researchers profile and advice on their selection
1.7. Scientific preparation, on regulations and research processes
1.8. Scientific incident management: changes, protocol deviations...
1.9. Data review for analysis and preparation of statistical analysis
1.10. Final results report, with clinical and scientific assessment
1.11. Scientific communication in events: posters, presentation materials...
1.12. Article preparation and management of publication in scientific journals
1.13. Follow up and dossier of references and response to publications
7. 2. SERVICES FOR RESEARCHERS: SITE MANAGEMENT ORGANIZATION (SMO)
These services equip the research team with the necessary support, so they can focus on the
patients' clinical evaluation and assessment, satisfying professionally the remaining
requirements of clinical research. Among these services, we highlight the following:
2.1. Capture of studies adjusted to the researchers' interests and resources
2.2. Management of feasibilities and communication with promoters
2.3. Training of the research team (classroom-based and online)
2.4. Dissemination among the eligible population of information about clinical trials
2.5. Preparation of support materials for professionals and patients
2.6. Data management: collection, management and sending of data from the field
2.7. Supervision and consultation of the research team (in person and remote)
2.8. Communication tools for the research team and the promoter
2.9. Technological support and advice: research materials, IT…
2.10. Administrative support: collection management, documentation, databases…
8. 3. DEVELOPMENT AND MANAGEMENT OF RESEARCH PROJECTS
We cover from the statement of a doubt as a study objective to the dissemination of the results, with a
direct and exclusive communication with the customer. Among others, we include the following
services:
3.1. Methodological and scientific assessment (as described in section 1)
3.2. Biometrics: analysis plan, sample size, final analysis…
3.3. Capture of material and financial resources
3.4. Management of human, material and economic resources
3.5. Administrative management and regulatory process
3.6. Selection of researchers
3.7. Implementation in centres that include research training
3.8. Electronic CRF and clinical data management (described in section 4)
3.9. Technological and IT support of research materials
3.10. In-person and remote monitoring
3.11. Communication platform for researchers (described in section 5)
3.12. Medical writing: preparation of the study materials and publications
3.13. Publication management in journals and at presentation in events
9. 4. ELECTRONIC CASE REPORT FORM (CRF)
We have an online CRF for a safer, more reliable and more accurate data collection. It also allows us
to monitor the data and detect incidents immediately. It can be personalized and adapted to the needs
and resources of each customer. Some of its more outstanding characteristics are:
4.1. Pre-coding and data entry validation through automatic filters
4.2. Data quality control through random checks
4.3. Data Coding: ATC, CIE-9, MedDRA...
4.4. Graphic representation of analytical and clinical parameters
4.5. Visualization and edition of images and complementary tests
4.6. Individualized automatic alerts by mail
4.7. Management and communication of adverse reactions
4.8. Online monitoring of individuals, data and activity
4.9. Automatic writing of clinical reports
4.10. Sending of information through HTTPS, and SSL transactions
4.11. Confidential information: encrypted through own algorithms
4.12. Technical support for users through a personalised call centre
10. 5. ONLINE COMMUNICATION PLATFORM
We have developed an online platform to improve the communication, follow-up and information
monitoring of each researching team and of every study or project. This platform can be included in a
wider research net (Meditenet) or be implemented specifically for a single group or project on demand.
5.1. Creation of individual, group or project profiles
5.2. File management, with reading and download control
5.3. Forum, chat, video conference and virtual meetings for members
5.4. Webminars and e-learning tools
5.5. Task assignment and control
5.6. Complete activity monitoring, producing reports
5.7. Export option for all group and project elements
5.8. Technical and user's support by trained personnel
5.9. Possibility of including the customer's own applications
5.10. Multi-platform: Windows, Mac, Android, IPad, IPhone, Windows Phone…
