Our team of highly qualified clinical project managers have vast experience across multiple therapeutic areas including, but not limited Biosimilars, Dermatology, Ophthalmology, and Vaccines among many others. This knowledge combined with the use of efficient technology devices creates a conducive environment for the production of accurate and timely results. Better yet, we are up to date with the leading trends in the field of science. Therefore, we have an edge against our competitors in solving problems that arise in this field.
Etico Research provide expertise in:
At the centre of any Etico Research project is the medical and scientific team. These highly qualified doctors and scientists work closely with one another to make certain that every aspect of the research is well done. The blueprint used to conduct the trials and the study method used to assess the research is selected carefully by a team of qualified research medics. Also, a high level of caution is taken so that the outcome of the study is free of any errors. The recommended GCP standards are upheld every step of the way and that the critical points are captured efficiently.
Etico Research’s medical monitors come from diverse therapeutic backgrounds, and have the clinical and research expertise required to provide rigorous medical oversight of clinical trials. According to the needs of the trial, our medical monitors are able to provide a number of services, such as:
Our Solutions, tailored to customers’ requirements include Phase II – IV Clinical Trials, Late Phase / Real World studies, Regulatory Submissions, as well as complex surveys and observational studies.
Our Solutions:
1. Statistical Inputs to Study Design
2.Sample Size Calculation & Justification
3. Protocol CRF Review
4.Randomization
5. Statistical Analysis Plan Development
6.Specification & Data Sets
7. Statistical Report
8. Statistical Analysis and Programming Services.
Our experienced safety and pharmacovigilance team provides:
1.Full safety service requirements including safety database
2.Tailored solutions for commercial and academic research across all phases
3.A service that is adaptable, yet able to maintain the highest regulatory and ethical compliance
4.A thorough understanding of safety reporting requirements across trial countries
The tools used in the process improve efficiency, reduce costs, and help reach the milestones at an accelerated pace. We are capable of handling small to large-scale studies, from local sites to global ones.
Some of our services include :
Etico Research regulatory services can assist sponsors through the varied local regulatory and ethical requirements to ensure the most efficient start-up of a clinical trial. Our service provision is flexible and can be structured to best fit your needs. Such services include: