Clinical Development
Clinical Development

Clinical Development team conducts Phases II-IV clinical trials for pharmaceutical and biotech companies, maintaining the highest standards of ethics, quality and confidentiality. A team of well-trained professionals, experience in project management in various therapeutic areas.

To ensure our clients receive quality monitoring services in compliance with the applicable regulatory guidelines, we provide comprehensive training and development programs to our Clinical Research Associates (CRAs).

a) Project Management:

  • All projects are efficiently handled by qualified project managers who are experienced in various therapeutic areas, like Oncology, Endocrinology, Gastroenterology, Cardiovascular, Dermatology, Infectious diseases, Neurology, Immunology, Orthopedics, Respiratory and Metabolic disorders.
  • Our project managers act as a single point of contact for Sponsors throughout the duration of the study, ensuring quality deliverables within the timelines and budget. Protocol-related queries and safety / clinical concerns are addressed through close collaboration of the project managers and medical monitors, ensuring the integrity of clinical trial data and also the principles to be followed to carry out the clinical trial services in India.

b) Site Management:

  • The Clinical Development team selects each study site based on the site infrastructure and access to appropriate patient population. A recruitment and retention plan unique to each site is prepared, focusing on the site's strengths and experience. We have well-established relationships with hundreds of study sites across India and work closely with each site to develop successful recruitment and retention strategies.
  • Site management also covers up gradation of site infrastructure to meet clinical trial requirements. We continuously identify new investigators and train them to enrich the investigator database across different therapeutic areas. Site finance management is also handled by our team.
  • We do offer Study Feasibility; Site Monitoring, Site Selection, Audit and Reports which are commonly found in clinical trials services in India.
  • Ethics and regulatory submissions

c) Clinical Trial Monitoring :

  • CRAs add value to the conduct and timely execution of clinical projects using clinical trial project management services. ICBio's CRAs with Life Sciences or Medical background are the main strength of the Clinical Development department. They have strong organizational skills, eye for detail, good written and oral communication skills. Our CRA's are trained in the ICH GCP guidelines and relevant national and international regulations. They travel to the study sites every four to six weeks or as per the sponsors' monitoring SOP to ensure quality data, protocol adherence and compliance to regulatory guidelines. Regular telephonic follow-up with study sites and weekly status updates to the sponsor are systematically conducted by every CRA. They also monitor drug dispensing procedures and drug accountability. Their other tasks include source data verification, data collection, safety reporting, informed consent form review and resolving data queries.
  • The team has working knowledge in handling e-systems like Enterprise Project Management, Electronic Data Capture, Clinical Trial Management Systems, Interactive Voice Response Systems and Interactive Web Response Systems.

d) Clinical Trial Supply Management:

  • ICBio provides end-to-end management of clinical and ancillary supplies. Our team develops a customized logistics model to meet the unique needs of the sponsor, while ensuring adherence to SOPs of ICBio / sponsor and regulatory guidelines. Our project management expertise, backed by supporting technologies provides a deeper insight into the supply needs for each protocol.
  • Our service begins with providing assistance in obtaining import license and custom clearance of clinical supplies. Depending on the requirements of the sponsor, we also take the responsibility of drug destruction. We have dedicated pharmacists responsible for storage, handling, and accountability of clinical trial supplies and an enterprise resource program to manage the inventories of all supplies.
  • Our facility has a separate 700 sq ft access controlled, clinical supplies unit that maintains temperatures between 15-20°C and 2-8°C. This unit has an electronic temperature monitoring system along with an auto alarm system. Cold chain shipment is provided using reliable courier agencies for the distribution of drugs to investigator sites. Temperature loggers are used during shipment, to ensure proper temperature control and record maintenance.

Clinical Monitoring:

Regular and continuous Monitoring of Clinical Development is essential in assuring safe subjects, quality data and a well-executed study. For every phase of clinical monitoring, ICBio will provide the timely regular manner, a detailed report after each completion of clinical monitoring service.

ICBio medical experts provide round the clock clinical-monitoring services onward with clinical trial management system and also scientific and medical support for project managing teams and investigator sites to meet strict timelines for regulatory compliance and Adverse Event enquiry, collection, evaluation, classification, reporting and total drug safety management. Also to make sure efficient communications with client's organization, an expert serves as your point of contact for all aspects of your study all the time.

Between various monitoring visits, ICBio clinical research associates call investigators on a weekly basis to verify patient enrollment situation, assess study progress, reply protocol questions, discuss CRF completion and ensure the study progresses in a timely manner. Clinical Research Associates make final visits to sites to close studies after all subjects have completed or have been discontinued from the study and after all queries have been answered. This is the procedure which ICBio Labs employs for ensuring successful monitoring of things all through the Clinical Trial Process.

e) Vendor Management:

  • Based on the Sponsor requirements, ICBio also provides Vendor coordination and management as a key service. Our Clinical Development project managers serve as the single point of contact assuring uninterrupted communication and coordination with third parties. We have in place SOPs for vendor management which provides oversight on coordination, structure and performance standards.
  • ICBio as one of the top Contract Research Organization in India offers other services like medical writing services and also a good clinical practice.
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