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Start-Up

In INFINITE we support you to the supervision and administration of all start-up processes that cover all the regulatory procedures that must be carried out prior to the start of a clinical research protocol. Our flexibility as an organization allows us to help you from the initial translations or the adequacy of the research documents to the submission of the information to the regulatory authority.

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Start-up Services

Our start-up services cover all the regulatory processes that must be carried out prior to the start of a protocol, these can be added in a modular way according to the needs of the client, the services we offer are:

Identification and evaluation of researchers

Identification and evaluation of research sites

Submission to ethics and research committees

Health authorization of the clinical study

Import permits

Adequacy of research documents

Foreign trade (import and export of inputs)

Contract administration with central and local sites and laboratories

Research documents

For the beginning of any operation related to clinical research it is necessary to support it with the correct documentation, which is why INFINITE has a team of specialists that support you for the development, validation or legalization of documents for research. Some of our services include:

Development and review of research protocols

Preparation, review and adaptation of FCI (Informed Consent Format)

Tropicalization of study documents

Simple and / or certified translations

Development of CRF and eCRF (Case Report Form)

preparation-documents-research

Compliance with Labeling Standards

The information or texts included that contain the labels and instructions of the medicines, herbal remedies and medical devices, are considered health and commercial information which identifies each product, in order to accurately establish its correct identification in the market, for sale and supply, as well as to guide and warn the consumer or patient about the proper and safe use of these health supplies.

These texts must be authorized and delivered by the Ministry of Health either by obtaining a sanitary registration of the medication, the alphanumeric code of herbal remedy or modifications to the registration conditions. INFINITE, as an expert company in the registration of new medicines, offers you its orientation services for compliance with the Official Mexican Standard for the labeling of medicines and herbal remedies (NOM-072-SSA1-2012) so that the product has all the requirements established by the authority and can operate its marketing activities without inconvenience.