SMO - INVESTIGATOR IDENTIFICATION

Rather than start from scratch in identifying investigators, our continuously updated database eliminates much of the legwork that our client would otherwise have to do in gathering basic information. Our relationship with specialists from diverse therapeutic areas helps us pre-qualify sites. We can quickly shortlist investigators and sites across a range of parameters including:


  • Investigator qualification
  • Specializations
  • Patient population
  • Clinical trial experience
  • Infrastructure capabilities (Lab, Radiology, Nuclear Medicine, etc)
  • Healthcare capabilities (General Nursing Care, Emergency Care, Intensive Care, etc)
  • Lab accreditation and internal or external quality assessment details
  • Availability of support staff for the study (Coordinator, Nurse, Lab Technician, Medical Officer etc)
  • Availability of dedicated study office with fax, phones, internet etc
  • Availability of IRB or access to IEC
SMO - SITE EVALUTION

We assist you in speeding up your site evaluation process by either providing you with a ready shortlist of prospective investigators from our own database or by quickly and efficiently reviewing the sites you have identified. Evaluation of sites from Altree's database would be faster as we have already done the basic due diligence to establish a site's viability to meet the protocol requirements. Alternately, if you have a list of sites that needs evaluation, our experienced personnel can visit the site to gather the required information, provide comprehensive feedback on feasibility, and establish a working relationship with the investigator and his/her team. Our focus is on assisting the site through pre-initiation and brings it to a stage of readiness for site initiation.

SMO - STUDY TEAM TRAINING

Most sites in India are new to clinical trials. Consequently, training and preparing them for participation in clinical trials is extremely important. Our approach to training is holistic and we focus on imparting more than just a mere understanding of the procedures to be followed. ICH-GCP education is compulsory for new teams which makes them well versed in international guidelines, rules, and regulations governing clinical research. We also offer a short course covering the history of clinical research and current best practices. This enables the study team to gain a better perspective of their contribution and avoid the typical pitfalls that new teams may get into. In addition to such generic training, we also provide protocol specific training as part of site initiation. This includes simulated runs of the informed consent, screening, and randomization procedures. The primary focus of our training is to equip the team with the necessary know how to make the trial a success. We go the extra length in educating them on various aspects of the trial including such matters like drug accountability, follow up visits, documentation.

SMO - INDEPENDENT ETHICS COMMITTEE

If your site does not have an Institutional Review Board we can facilitate access to a commercial Independent Ethics Committee (IEC) qualified to review protocols, provide feedback, approvals, requests for modification, and so on. The IEC provides prompt feedback within a specific time frame (usually ten days) and meets regularly. All IEC members have undergone ICH-GCP training and have experience in reviewing and discussing important aspects of the protocol, informed consent form, investigators brochure, etc, before providing their opinion.

SMO - Site Infrastructure Provisioning

The logistics involved in equipping a site in preparation for the trial can be distracting. Supplying refrigerators, freezers, centrifuge machines, stationery, fax machines, cupboards, etc can get overwhelming and confusing when dealing with unfamiliar suppliers and courier companies. Our knowledge of the local market helps us identify and select the most cost-effective suppliers and transport organizations to do the job with a minimum of fuss and maximum transparency. We can assist you with the infrastructure provisioning of the site quickly and efficiently.