Solutions

We have experience with Synthetic, Biological and Herbal Medicines, Health Products, Advanced Cell Therapy, Vaccines, Cosmetics and Food. For products that require Phase I, II, III clinical study or post-Marketing / Phase IV Clinical Study studies, we offer:

REGULATORY CONSULTING

For innovative products or for product that will need Clinical Research for registration;
Product classification according to the different regulated areas of ANVISA;
Clinical Rationale and legal scope development that the product must meet with regulatory authorities;
Therapeutic Experimentation Report development;
Dossier preparation for drugs and health products (DDCM and DICD for ANVISA);
Requesting meetings with ANVISA to discuss the best regulatory strategy for the product;
Support for product registration in other countries (FDA, EMA, ANMAT, INVIMA and other agencies).

MEDICALWRITING

Study Protocol development;
Clinical Investigation Plan;
Investigator’s Brochure;
Informed Consent Forms and Patient Information;
Laboratory Manuals;
Clinical Study Report;

TRIAL MANAGEMENT

Qualification of Vendors (partners for the different stages of the project);
Startup of studies (feasibility, qualification and initiation of research centers);
Support for ethical approvals (CEP and CONEP);
Import of Investigational Product and others;
Management of study drugs;
Training in Good Clinical Practices;
Blanck CRF design support;
Meeting of Investigators;
Initiation Visit;
Training and Retraining;
Monitoring Plan;
Monitoring (initiation, routine, administrative monitoring, pharmaceutical monitoring, medical monitoring, retraining, closing);
Project Management Plan;
Inclusion Management (FPI–LPI);
Management plan for deviations, violations, misconduct and fraud during the clinical trial.
Control of regulatory reports (ECs, CONEP and ANVISA);
Blind and non-blind team;
CRO and Sponsor Responsibilities Plan;
SAE management. and Pharmacovigilance;
Data Management;
Medical Coding;
Certified team for e-CRF building (REDCap and IBM platforms)
Quality audits;

PHARMACOVIGILANCE SERVICES FOR CLINICAL TRIALS

Qualified professional in clinical trial for capture, management and evaluation of Serious Adverse Events.
Case Narrative Writing for Reporting Adverse Events.
MedDRA coding.
Medical review and evaluation of safety information.
Elaboration of notification of suspected unexpected serious adverse reaction.
Individual case security information notification.
Preparation and submission of Periodic Safety Reports (PSUR, DSUR).
Azidus has procedures for performing the activities or we can use the sponsor's SOPs.

PHARMACOVIGILANCE SERVICES FOR POST REGISTRATION

Development of systems and processes that ensure that all adverse events are properly collected and reported.
Regular preparation of Periodic Pharmacovigilance Reports and submission of adverse events to Health Authorities.
Continuous monitoring of the safety profile of approved drugs, including signal detection, its assessment, alerts to the need to update package inserts and update regulatory information.
Routine Risk Minimization Activities: Activities developed to warn and inform about an adverse event, with the objective of reducing the probability of its occurrence.
Treatment of Previously Unknown Critical Information: information about the safety of a drug that is not available at the time of registration and that represents a limitation of safety data.