1. Large urban patient populations, close to 80% concentrated in a few urban areas. Treatment-naive patients available in all therapeutic areas.
2. Disease profiles and therapeutic standards resembling those of the US and Europe.
3. Smaller number of clinical trials competing for the same patients, which guarantees more patients per site.
4. High patient enrollment and retention rates due to close, trustful patient-doctor relationships.
1. Regulations and laws for clinical research aligned with international standards Seasonal reversal, enabling continuous enrollment.
2. Experience with FDA/ EMA, local regulatory inspections and sponsor audits.
3. Proven high-quality data. Most of the clinical research conducted in the region is part of multinational, industry-sponsored clinical trial efforts for FDA and/or EMA submissions.
1. Skilled MDs in all therapeutics areas, working not only private facilities but also public hospitals.
2. Laboratory staff with IATA certification and experience in PK sampling.
3. Investigators & research staff with English language literacy.
4. Expertise in working with IWRS and EDC systems.
1. Quality proven regional vendors for support services (drug distribution, sample transportation, cold-chain logistics, etc.)
2. High standard communications and IT.
3. Similar time Zone as the USA/Europe (0 – 5 hours difference).
