For sponsors and CROs

How working with us actually goes, from first contact to close-out.

From synopsis to first patient in

No surprises, and no timeline we do not believe.

Feasibility

You send the synopsis and eligibility criteria. We assess them against our actual patient base and referral network, and answer with a realistic number — including "this one is not for us" when that is the honest answer.

Regulatory submission

CEP and, where required, CONEP. In parallel, ANVISA authorisation and import licensing for investigational product. This is usually the longest stretch of Brazilian start-up and should be planned as such.

Site initiation

Team training on the protocol, source documentation set up, investigational product received and reconciled, and the first participants identified from our referral base.

Recruitment and follow-up

Participants are recruited through our own registry and referral network, tracked with a full audit trail, and followed per protocol. Recruitment status is reported at the agreed cadence — including when it is behind.

Monitoring and close-out

On-site and remote monitoring, query resolution, and archiving per ICH-GCP and Brazilian requirements.

What we ask of you

A site relationship works in both directions.

Realistic timelines for Brazil

Brazilian regulatory review is not a formality and cannot be compressed by the site. Plans that assume otherwise fail at start-up, not at the end.

Protocol documents in advance

Full synopsis and eligibility criteria at feasibility stage. Assessments based on a title and a therapeutic area are guesses, and we would rather not give you one.

Translation and cultural adaptation

Participant-facing material must work in Brazilian Portuguese for this population. We will flag wording that will not land here, including in the informed consent form.