End-to-End Clinical Monitoring

Seeded with the study synopsis, nurtured into a study design and brought up to ethical clinical trials across the globe, thus a cycle of documentation, medical writing, trial site management and monitoring through in-house CTMS and glide across the regulatory compliances.
 

SPLIFE is a full-service CRO with capabilities across all phases of clinical development. Based on client and project needs our project team is built to provide the therapeutic expertise at all stages. We are the Partner of Choice across all areas of the clinical program, from protocol development to regulatory submission enabling the highest level of quality and efficiencies. Hence with our focused scope of work, we deliver the utmost quality deliverable at the most affordable rates.

Protocol Development - Reliant upon phase of development and hypotheses to be addressed, the scope of data reviewed includes all aspects of pharmacokinetics that might potentially form the design of an investigation. All sanctioned protocols are fully vetted through the operational components of the organization, with full knowledge of logistical and financial implications in addition to the clinical and regulatory implications.

Feasibility - The feasibility department helps on site selection, regulatory and logistics issue resolution, ethical standards, possible recruitment rates, determining the number of sites required for a completion of a study within a designated time period, options for local purchase of concomitant and study drugs and other clinical materials.

Project Management - We support the study with the backbone of project management of teams, trainings, milestones, deliverables, vendors, status report and QC.

Investigator support - We have teamed up with the investigators with unfathomable experience across multiple therapeutic specialties such as neurology, cardiovascular, dermatology, allergy and oncology. This assures the proficiency with each study protocol and hence a well conducted and monitored study for utmost results.

Patient recruitment support - The identification and selection of investigators as per sponsor expectations and investigator expectations is planned out. The maximization of patient recruitment and enrolment is ramped up. We benchmark to achieve recruitment targets by planning for recruitment with adaptive trial designs.

Trial Site Monitoring - Our extensive clinical trial conducts, highly trained CRA's, thorough knowledge of local regulations and GCPs in lines with ICH E6, access to cutting-edge study management tools and the latest data transmission technology guarantees effective and efficient management of investigator sites.

Medical Translations - We serve with medical translations of the local languages across the globe for the data collected during the study.

Regulatory Affairs - Our regulatory affairs activities include all types of projects, from global to local submissions. The domain armed with the specialists and the strategist aims to provide integrated service both in terms of clinical trial management and consulting for regulatory processes.

Quality Assurance - Right from the inception of SPLIFE, Quality Assurance has been the niche foundation of all the services that we render. Being ISO 9001:2008 certified and audited, our pulse lies in our quality of our deliverables. We have individual quality auditors for every service that we have been serving across the decades of our existence.

Call SPLIFE today to help solve your Clinical Operations challenges..
 
 
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