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Scientific consulting services

                CLINICAL RESEARCH

 

With activities in dozens of projects in the most diverse specialties, SCIUTO has in its DNA the Clinical Research area. Our work together with researchers who participate, in an integrated way, from the beginning of protocol development until the end of the last patient's treatment allows us to deliver transparent and objective results for the sponsor.

 

  • Protocol and term design, linking opinions between teams: sponsor, research center and SCIUTO.

  • Feasibility of research centers, institutions and autonomous researchers.

  • Logistic and technical organization for meeting researchers and staff.

  • Development of layout and technical elaboration for CRF questions, evaluations, scales, journals and forms, with individual validation.

  • Advice during the publication of results.

​                          STATISTICAL AND

                   SCIENTIFIC CONSULTING

 

1. Advice on the most appropriate design (product development support, product registration, post-registration changes, post-marketing studies).

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2. Statistical plan of protocol synopsis.

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3. Outline of the protocol.

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4. Statistical management and analysis of clinical trial data: Phase I, II, III and IV studies, bioequivalence studies.

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5. Interim analysis and post-closure analyzes of the study.
               
6. Determination and justification of the sample size calculation in clinical trials in function of the hypotheses of the study (non-inferiority, superiority, equivalence and bioequivalence) and the study design (parallel groups, cross-over groups, factorials Design).

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7. Counseling and statistical analysis of observational clinical studies or epidemiological studies for all medical specialties.

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8. Elaboration and execution of systematic reviews and meta-analysis of studies of the scientific literature for the pharmaceutical industry. We offer sensitivity study techniques using the tools of meta-regression, analysis by subgroups, funnel-plot, etc.

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9. Statistical Reports: Statistical Writing.

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10. Medical Writing in clinical trials.

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11. Training in Company: customized training for the pharmaceutical industry in relation to the interpretation of scientific studies, bibliographic reviews and meta-analysis, and statistics applied in clinical trials.

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12. Courses, workshops and conferences on topics related to clinical research and biostatistics for clinical researchers, physicians and Medical Science Liaison (MSL).

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13. Experience in response to ANVISA's observations and requirements (written and face-to-face with regulatory authorities).

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14. High-quality electronic Case Report Form (e-CRF) developed exclusively by SCIUTO with the greatest difference in the medical overviews of the progress of the project and the possibility of carrying out intermediate clinical and statistical analyzes at the Multidisciplinary way along with sponsor and opinion leaders.

                       EVALUATION OF

             HEALTH TECHNOLOGIES

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  • Elaboration of studies on Health Technology Assessment (ATS).

  • Development of strategic studies to include products in the public and private market, with emphasis on studies aimed at the inclusion of products in hospitals:

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* Modeling for the study;
* Analysis of market-focus specificities;
* Characterization of the patient profile (diagnosis x target market).

                ANALYSIS OF PROJECT        OPPORTUNITIES FOR NEW PRODUCTS

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  • Analysis of projects based on the "360º Evaluation" - the main aspects related to the adoption of new projects are studied:

* Clinical-Regulatory Evaluation

* Medical-Scientific Evaluation

* Technical evaluation

* Evaluation of Supplies

* Patent Evaluation

* Market Assessment

 

  • Risk analysis of new opportunities.

  • Pipeline planning.

  • Participation of client teams in the preparation of the evaluation.

                     REGULATORY AFFAIRS

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SCIUTO presents an innovative proposal for action in the area of ​​Regulatory Affairs in the scope of registration and post-registration of medicines.
With a team of professionals specializing in national and international health regulation, with extensive know-how in clinical research, new biological and biological medicines, synthetic and semi-synthetic medicines, SCIUTO's proposal is to offer a personalized service per company, customized by project, guaranteeing Compliance with the legislation currently in force.

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                   Definition of regulatory strategy

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For all drug categories: new, generic, similar, specific, biological and new drugs.

  • Feasibility analysis and preparation of regulatory strategy for registration.

  • Feasibility analysis and preparation of regulatory strategy for new product development, incremental innovations (including fixed dose associations) and new biological product or biological product (via comparability and individual).

  • Regulatory feasibility analysis and proposition of adequacy strategies for products acquired from other companies with registration already in force in Brazil.

  • Adequacy of drug registration renewal process.

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                       Biological / biosimilar products

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1. Preparation of registration and post-registration dossiers.
• Evaluation and orientation of the appropriate regulatory route for submission of biological product dossier (comparability or individual development).
• Regulatory feasibility assessment of registration dossiers of organic products candidates for registration through the comparability obtained in international markets and guidance on the regulatory strategy for dossier submission in Brazil.
• Elaboration of DDCM and specific clinical trial dossier, including clinical development plan, investigator's brochure and experimental drug dossier (with the comparability exercise for products developed via comparability).
• Elaboration of strategy of comparability (molecular, non-clinical, clinical and immunogenicity) for biological products.


2. Critical analysis according to ANVISA's standards of comparability studies already available on products obtained from other companies, subject to technology transfer or not.

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3. Elaboration of a clinical development program for organic products through individual development.

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4. Elaboration of a clinical development program for biological products via comparability with approach to aspects of immunogenicity, extrapolation of therapeutic indication and interchangeability / substitution.

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5. Elaboration of post-registration changes strategy, especially related to the change in the manufacturing process of the asset, inclusion and change of the place of production of the asset and scale up.

 

                             Scientific advice

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New Molecules, Incremental Innovations (including fixed dose combinations)

  • Elaboration of DDCM and specific clinical trial dossier, including clinical development plan, investigator's brochure and experimental drug dossier.

  • Elaboration of clinical strategy for registration (Pk / PD, Ph II, Ph III, confirmatory bridge studies).

  • Elaboration of Technical-Scientific Opinion and Report of Clinical Trials with the following objectives:

* Presentation of clinical rationale and clinical trial report for registration dossiers, post-registration inclusions and registration renewal.
* Elaboration of Clinical Trials Report, along with clinical overview, following the CTD model (Module 2, 4 and 5).
* Submission to CONITEC for the incorporation of new technologies.


                       Technology transfer and PDPs

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  • Project feasibility analysis including regulatory risk analysis and proposing a regulatory strategy to make the project viable.

  • Orientation and structuring of the Technical Internal Regulatory Committee involving the transferring and receiving companies of the technology.

  • Monitoring and regulatory guidance in the different phases of technology transfer.

  • Elaboration of executive project for submission of new PDPs or adequacy of PDPs in MS, including risk analysis.

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         Post-registration of pharmaceutical products

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                 For New / Similar / Generic

  • Preparation of technical report. Focus on DMF issues and degradation products.

  • Preparation of post-registration change requests with pharmacotechnical and clinical focus.

  • Adequacy of post-registration petitions not yet framed in RDC 48/09 and its updates.

  • Preparation of regulatory audits. (Preparation and adequacy of pre-audit documentation and procedures and / or post-audit adequations).

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