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- Email
Info@galaxycrservices.com -
- Office Hours
Mon - Sat : 9am - 6pm
GALAXY CR SERVICES is a site management Organization (SMO) that acts as a common platform between the investigators, institutions and sponsors/CRO for the execution of Clinical Research study/trial process.
It is actively engaged in providing site management services (Phase I-IV) to global Sponsor(s)/CRO(s) across multiple therapeutic areas by providing professional services and real-time assistance to investigators and study sites of non-medical judgment work of clinical trials, in order to improve the study quality, accelerate the project process, and promote the standardization of clinical trials.
Qualified study coordinators and site management associates are key to the successful management of a clinical trial.
Galaxy CR Services provides highly qualified and experienced Study Coordinators (SCs) and Site Management coordinator s (SMCs) to help support both principal investigators and sponsors. Through our SMO service, we provide principal investigators with trained SCs to assist with daily clinical trial activity and patient recruitment; and sponsors with experienced SMCs to provide clinical trial site management and ethics committee support.
CR services having local knowledge and teams on the ground facilitates close contact with investigators. The existing relationships of our teams, with investigators are fully leveraged during our feasibility process and throughout the study.
Strong and established relationships with experienced investigators help to facilitate a timely and comprehensive feasibility assessment to ensure the most appropriate and best recruiting sites are chosen for our sponsor’s projects.
Galaxy CR Services Assist the sponsor while conducts the site feasibility’s to identify potential sites for a particular therapeutic area and also identifies the suitable investigators for a particular indication.
We help Principal Investigator to understand in depth of feasibility questionnaire through discussion and available record so that accurate information can be made available which helps to avoid poor enrolments if the site is being selected. We suggest the right investigator from the site to sponsor with utmost care so that projected enrolments and data quality can be achieved.
Galaxy team will help to smoothen the site selection process by scheduling a convenient date for sponsor and investigator by getting prior appointment from investigator and other study team. Galaxy designee will support sponsor during the site tour. The necessary documents related to investigator, laboratory, ethics committee, equipments, site SOPs etc., will be made available. Galaxy designee with help smoothen the site selection process.
Assistance in the execution of CDA, Undertaking by the Investigator Form FDA 1572, Financial Disclosure, Budgeting, Clinical Trial Agreement etc. Preparation and submission of EC dossier and follow-up on queries (if any) Development of study specific SOPs.
Development of patient recruitment strategies
Development of Study management plan
Managing Logistic and operation challenges
We will ensure that all the protocol specific requirements such as trained team, equipments, calibrations and other basic infrastructure are at place by coordinating with the sponsor/CRO.
Successful recruitment has a significant impact on the clinical trial timeline. According to research data, recruitment accounts for 70% of clinical trial delays. Improving patient recruitment rates offers a major opportunity to speed up the clinical trial and product registration.
We develop patient recruitment strategies with our local experience and our understanding of the patient’s pathway, thereby identifying the cause of recruitment failure/lost follow up, and provide mitigation plan to retain patients in the study.
Our trained co-ordinators make the good liaisons and work as an catalyst to enroll the subjects by various strategies permissible by regulatory authorities. Not only enrolment but our co-ordinators do their best efforts to stop the drop-out by the subjects from the study by paying the full attention and by solving their difficulties in compliance of trial.
The Galaxy cr services team keep the track of site activities in form of progress report for the particular protocol and report to the PI and Sponsor /CRO in regular intervals This help in the proper analysis to rectify the strategies for smoothening the study conduct.
Quality assurance (QA) plays a key role in the data integrity of clinical research. Good clinical practice defines quality assurance as the systematic and independent examination of all trial-related activities and documents. Audits determine whether the evaluated activities were appropriately conducted and data generated, recorded, analyzed, and accurately reported according to protocol, standard operating procedures (SOPs), and good clinical practices (GCPs).
The Galaxy cr services team keep the track of site activities in form of progress report for the particular protocol and report to the PI and Sponsor /CRO in regular intervals This help in the proper analysis to rectify the strategies for smoothening the study conduct.