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.

Project Management

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

Site Management

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