The authentication of the RAHE Life Science(RLS) QA team is international training and experience in clinical research methodology and management, with a mandate to ensure compliance to international standards, ethics and GCP. The team focuses more on preventive than corrective actions to minimise issues that may arise from non-compliance. Our staff is experienced in Phase I to IV studies in drugs, devices and biologicals for both innovator and generic products and strives to continually improve internal systems to exceed sponsor expectations.
The QA team has been providing study audit services to its existing clients with the goal being to avoid regulatory deficiencies. Our team has wide experience of working at the site, sponsor and CRO environments and thus has a high understanding of the local cultural intricacies in the various countries and regions we serve. Advice from the Regulatory team is an added feature of the services provided by the QA team to its clients. Our auditors have an eye for detail, capabilities for re-construction of study events and gap identification with regard to non-compliance to SOP, GCP and applicable regulations. RLS lists its audit observations in confidential reports which are provided to the sponsor along with advice for immediate corrective action and systems improvement. Corrective Action Plans(CAP) are reviewed for adequacy and evidence prior to closing audit findings. Audit observations are presented to sponsors by classifying them into minor, major and critical findings with specified timelines for reporting each of these classifications.
Every document is prepared in close association with sponsor’s representatives. Typically the turn-around time for a clinical study report is 3-4 weeks.
The medical writing group has access to excellent translating services ensuring a fast turnaround time for clinical trial documents ranging from patient information to diagnostic tools and Investigator Brochures. The translation process is coordinated by experienced RLS personnel with medical/ pharmaceutical expertise to ensure accuracy and consistency in content and style leading to quicker submissions and earlier study start-up.
