Clinical Development Services
Clinical trials are integral part of Drug Development. ICBio CRO offers end-to-end services for Phase II to IV clinical trials on small molecules, large molecules and medical devices with fully ICH GCP compliant operations.
A team of well-trained, experience professionals apply their therapeutic, regulatory and operational expertise to consistently solve the challenges that arise during all clinical projects. Clinical operation team conducts phase II - phase IV clinical trials, with ethics, high quality and confidentiality.
Our competency in project management is comprehensive and consistent processes, which conform to global regulatory requirements, from start-up to completion, performance is monitored regularly and measured against contractual timelines. In addition, project costs are tracked to ensure adherence to agreed budgets.
We appoint experienced and qualified project managers who are experienced in various therapeutic areas. Project Managers work closely with the sponsor, project team from project kick-off and start-up through completion of the final study report or contract closure to meet their objective.
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. Project teams typically consist of a project director, a project manager, a team leader, site monitors and clinical trial assistant.
The project manager’s responsibility:
- Efficient Project Planning & seamless execution
- Allocation of Project Resources
- Meticulous Site Identification and Assessment.
- Contract Management
- Vendor Management
- Develop Monitoring Strategy
- CRA Training
- Monitoring Trip Report Review and Submission
- Proactive Risk Management
- Quality Assurance
Our site management team bridges the gap between sites and sponsor/CRO in accelerating patient enrollment and effectively managing the trial from start to finish; thus ensuring smooth transit of the trials to the next phase.
With 150 sites across India in 17 cities with 18plus therapeutic areas expertise, we provide access to more than 150 sites and a large network of highly qualified investigators.
Our site have highly qualified and trained clinical research coordinator (CRC) at each study site to assist the investigator and site staff with all day-to-day study activities.
The roles and responsibility of CRC includes:
- Protection of research subjects
- Ensuring accurate of data
- Regulatory submissions
- Site preparation for the clinical trial
- Additional staff training
- Interacting with EC/CRO/Labs/Sponsor/PI
- Maintaining clinical trial documents/records
- IP accountability
- Scheduling patients’ visits and ensuring retention till study completion
- Keeping the investigator informed and compliant
Clinical Trial Monitoring
Our clinical monitors are the backbone of every trial conducted at ICBio. Their priority: High-quality data for your regulatory submission.
Our skilled and well-trained clinical research associates (CRAs) ensure the highest quality review of data and effective interaction with study sites. Our CRAs conduct on-site monitoring visits throughout the study to:
- Oversee data collection
- Review source documentation and case report forms
- Ensure regulatory compliance
- Resolve data queries
- Conduct interim analyses as requested by clients
Our CRAs are dedicated and qualified for site monitoring, providing understanding of local languages, regulations, customs and business practices
Our clinical monitoring teams deliver faster, more efficient investigator site support and data oversight
- Specialized therapeutic training.
- On-site monitoring, familiar with local customs and regulatory requirements.
- The right approach to monitoring clinical trials.
Our Medical & Safety Monitoring staff, all Physicians (MDs) averaging 5 years of trial experience oversee the protocol eligibility and ensure compliance to national and international guidelines on safety reporting allowing our project teams to execute projects with superior precision in almost every therapeutic area:
Clinical Trial Supply Management
ICBio capabilities include warehousing and distribution of investigational drugs and clinical supplies. These services are often provided as a part of a full clinical services contract but can also be availed of on a stand-alone basis. ICBio has worked with clients in providing CTS management for their clinical trials, the majority being multi-centric Phase III trials. Our facility has been audited by all our sponsors. This has in turn helped us continuously improve our services to meet changing sponsor and regulatory requirements. We have tied up with a logistics services provider to look after your specific requirements.
Our CTS Management services include Procurement of import license, Customs clearance of import shipment, Receipt of inward bulk shipments, Management of local shipments to sites, IP labeling and Randomization generation, Experience with IVRS, Storage of investigational product and other trial supplies, Inventory management
- Quality Assurance
- Quality management provides quality systems which in turn guarantee good quality data in each clinical trial. Quality systems implemented at ICBIO and managed by Quality Management ensure the quality, integrity, and accuracy of data for each clinical study undertaken at ICBIO.
- 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.
- Bio Analytical
- ICBio management & operations team brings in considerable experience in conducting BA/BE studies on healthy as well as patient population with various dosage forms including injectables like IM/IV/SC, oral dosage forms like solid formulations (Modified Release preparations), liquid formulations, topical preparations and inhalations. The BA/BE studies conducted at ICBio are fully GCP compliant.
- Project Management
- ICBIO's project management group stands out from other CROs in an industry where hard deliverables and quality of enrollment are everything. ICBIO project managers throughout the globe are obsessive about on-time project delivery from day one.
- Our focus is to ensure the integrity of your data and organize your findings and conclusions into a clear and results-oriented presentation. Our bio statistics for clinical research and statistical programming services include pre-analysis, analysis and post-analysis.