Clinical Operation

Clinical Operation services

Clinical Operation

Biosphere provides end-to-end clinical operation services from site feasibility to close out. Managing clinical operations is a crucial part of clinical research. We understand the critical issues that can surface during clinical trials. Our Clinical Operation Services are designed to utilise intelligent technologies and expertise of our team members for enabling data collection and facilitating trial management in the most effective and ethical manner.

We have a highly experienced and efficient team of Clinical Research Associates (CRAs) to manage clinical operations for clients. Our customised solutions are developed after elaborate discussions with clients regarding the project goals and challenges. Inputs are also gathered from our team of regulatory experts and Quality Assurance (QA) experts.

We strive to bring together the best talent that can add immense value to a project. The resources will be allocated as per the project goals.The communication channels will be identified as per the location of the project members and the infrastructure required to run the trials.

Service Offered

  • Budget management for clinical trials
  • Site selection and initiation
  • Site monitoring and training
  • Source data verification
  • Managing timelines and deliverables for clinical trials

Benefits

  • Our CRAs are well-trained to manage onsite as well as remote monitoring.
  • Our team is well-versed with compliance issues and guidelines needed for conducting clinical operations in an ethical manner. They are aware of the industry-relevant ICH-GCP guidelines and Declaration of Helsinki and ensure that the trials conducted are complaint with these.
  • We thoroughly review source documents, case report forms and swiftly resolve the raised queries.

Speak to a member of our team about our clinical and safety data services

Our expert will work with you to gain insight to your molecule, anticipated outcomes and definite trial requirements and provide a customised design best suited for your molecule.

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