OBSERVATIONAL AND LATE PHASE RESEARCH
3B Biotech Research has the right expertise and the capabilities to conduct Observational and Late Phase Studies
Our support to manage Regulatory Requests and enhance the Value proposition of your Product
Long-term safety and efficacy data are not detectable during the early phases of the Clinical Research Program. Regulatory Agencies, healthcare professionals and payers are increasingly demanding for additional data for new products in a Real World Setting.
- Phase IV trials
- PASS & PAES
- Comparative Effectiveness Research
- Observational (non-interventional) studies
- Patient Registry
- Health-related quality of life studies
- Patient-reported Outcome (PRO)
- Real Word Evidence studies
- Expanded access programs
- Health economics studies.
Our Clinical Research Services
Someone used to say: “If you fail to plan, you are planning to fail” Our PM experts, together with our lean-approach and mid-size structure, make easier the Project Management of your study, ensuring study milestones are met.
A network of sites and KOLs has been build-up during more than 20 years of experience in the field. We can provide you with a pool of sites and Investigators who may join your project and help you in moving faster your clinical program.
Scientific rigor and accuracy is what we offer. Our medical writing team may support you in the drafting and reviewing of clinical document from protocol to clinical study report writing.
Our “plus” is a team coordinated by a 20-years experience senior professional. A multi-lingual team and a panel of local national experts help you to respect timelines and ensure study start and updating run smoothly.
Our team of GCP/GVP & Auditors has more than 30 years of experience and may advice you on how effectively manage clinical studies and maintain an updated Quality System to reach the highest level of compliance.
Our monitoring concept relies on the idea that providing an effective support to investigational sites will positively affect the conduct of the trial. Our monitoring team is made of professionals with experience in various therapeutic areas and are a source of customer satisfaction feedbacks.
From the drafting of Data Management Plan to centralized monitoring, passing to query management and database lock are key services we propose to collect high quality and reliable data.
Digitalization of Clinical trials is essential to meet Client regulatory timelines. eCRF, eTMF and eCTMS is what we use to streamline your clinical trial processes.
When managing a study, our statisticians are involved since early phases and their close cooperation with PM, Data Manager and Monitors ensure the most accurate results. Our statistic support includes study design, sample size calculation, database design, statistical analysis plan, randomization coding and statistical report writing.
Through a Department dedicated to pre- and post- marketing Pharmacovigilance and Clinical Trial Safety Officers we ensure pharmacovigilance information are exchanged timely and properly, ensuring the safety of patients on clinical trials. We can support Sponsor on managing SDEA, SAEs, SUSAR and DSUR, as well as regulatory submission / notification.
You can simply rely on our qualified vendors. Alternatively, together with our QA team we can select and manage vendors on your behalf. Our main vendors include centralized labs and Phase I Units.