1 L O C A L E T H I C S C O M M I T T E EYour trial must be approved at the local ethics committee (EC)for the research site where you choose to conduct the trial.Meeting frequency is about every 30 days; many can haveaccelerated meetings upon request. We will translate anynecessary documentation and assemble the final dossier forsubmission. Learn more.

2 NATIONAL REGULATORY AGENCYINVIMA is Colombia's regulatory agency. After the localEC, your human trial must be approved by INVIMA if yourtechnology is either a drug or a medical device. Meetingfrequency is every 30 days. For all other technologies, onlythe local EC approval is required. We will include a clinicalsupply list with the INVIMA submission so that we getapproval to import your investigational product and anyother equipment or accessory for the trial. We can becomeyour Colombia legal representative so that we can file theINVIMA submission on your behalf. Learn more.

3 I M P O R T P E R M I TBefore shipping your investigational product to Colombia,you will need an importation permit from the Ministry ofIndustry, Commerce and Tourism (MinCIT). We canbecome your importer of record and apply for the permiton your behalf. Processing time: approx. 10 business days.

4 P R O D U C T S H I P P I N GAll major shipping companies (Fedex, DHL, UPS) have direct 1-3 day service to Colombia. You will ship your investigationalproduct to our custom free-zone address.

5 I M P O R T A T I O NWe will nationalize and store your investigational productat our INVIMA-approved warehouse in Bogotá. Processingtime: approx. 5 business days.

Interventional Concepts is a Miami, FL-based contract research organization (CRO)for life sciences startups looking to conduct their early-stage human clinical trials inColombia. We provide operational support services such as site selection, trial set-up, study project management, regulatory management, logistical management(importation, storage, distribution), patient recruitment, techno/pharmacovigilance,medical safety monitoring, adjudication of adverse events, data management, andstudy monitoring. Learn more.

T R I A L B E G I N S - P R O D U C TD I S T R I B U T I O N T O S I T EUpon your request, we will ship your investigationalproduct -and any other accessories or equipment importedfor the trial- to the research site(s). Your investigationalproduct can now be tested on qualified subjects.Processing time: 1-2 business days.

S T U D Y M A N A G E M E N T ,M O N I T O R I N G & R E G U L A T O R YR E P O R T I N GWe manage the trial on your behalf so that you haveone point of contact. INVIMA requires that everyquarter sites submit a report with the adverse eventsfor each trial. Serious adverse events must be reportedwithin 48 hours. We will coordinate with the site thatthis reporting is done promptly and correctly.

S T U D Y C L O S U R EWe will submit the required closure letters to both local ECand INVIMA, and return to you or distroy all remainingproduct inventory.

Interventional Concepts, Inc. | 2520 Coral Way, Suite 2120, Miami, FL 33145USA | www.interventionalconcepts.net

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CLINICALTRIAL

30-60 day regulatory approval

Over 30% cost savings

50-million with universal care

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