Services

Learn about our services

Discover more about our wide range of professional services. We are constantly updating our website to keep you up to date with all our offers. We are always at your disposal in case of any doubt or clarification.

Our services

Clinical Monitoring

Our team of CRAs is fully trained to ensure an optimization of resources and perform the review of data in the most effective way and improve the performance of researchers belonging to the sites involved in the study.
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    SmartCRO has the capacity and structure necessary to adapt our procedures to the different needs of each monitoring and development process in each study, maintaining quality throughout the process.


    Our teams are experts in optimizing resources and increasing the performance of the parties involved during the different phases of a clinical study.

Regulatory affairs

Our team has extensive experience in intermediating between the different institutions for the approval of studies and rigorously follows the guidelines and ethical standards, which are the key to exercise good research.
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    We handle the regulatory and ethics committee submissions and contacts in all the covered countries, using our local experts.

Medical Writing

Our medical writers  develop study protocols, Investigator’s brochure, informed consent form (CRF), diaries, clinical investigation plans and study reports in accordance with current regulations and guidelines. 
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    High Quality Documentation Writing and Preparation to Meet your Product Development and Commercialization Demands.


    SmartCRO consolidated medical writing services build upon our already-available scientific, technical, medical, regulatory and commercialization communications services to provide customers the added value that come with continuity and streamlined communications throughout the lifecycle

Data Management

SmartCRO’s Data Management Department is responsible for managing all aspects of Data Management and associated systems. We perform the CRF and databases design, guaranteeing the quality of the data.
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    - Planning of statistical analysis

    - Detailed design and review of CRD

    - Design, creation and validation of databases

    - Encryption and data encryption guaranteeing confidentiality

    - Determination of sample size

    - Data entry

    - Creation of Queries

Training

SmartCRO provides training courses in a proffesional context focusing on the more relevant information for your organisation in the day-to-day practice. The training courses have been designed in a way to lead to a superior consolidation of knowledge based on practical examples.
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    SmartCRO offers training courses on different topics: Monitoring of Clinical Trials; Management and Coordination; Data Management, GCP, Clinical Research and Medical Writing, Clinical Research Statistics, Interpretation of Statistical Results and Pharmacoeconomics.

Biostatistics

We perform statistical data analysis following international regulations and traceability based on the SPSS and SAS® statistical reference package.
In all our studies we made from the drafting of the protocol going through the development of statistical plans ...
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    (randomization, sample size calculation, etc.) to reach statistical programming (making reports and statistical analysis, as well as providing statistical advice to the medical community).

     

    We also perform the transformation of clinical data to standardize them and prepare all the necessary requirements in a regulatory shipment.

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