BCS conducts Phase II-IV clinical trials for inclusive but not limited to Pharmaceutical, Biotechnology, Medical device, Aayurvedic, Nutraceutical and Cosmetic companies.

Our clinical operations team is highly experienced by maintaining the highest standards of ethics, quality and confidentiality. We also support in effective site management services, ranging from site feasibility to site close-out. Collectively, the team has vast experiences in several therapeutic areas. Our Team is thoroughly trained in our SOPs, that meets the international standards. We are dedicated and ready to face all the challenges in the most complex journey of Drug Discovery, Clinical Trial, by taking it successfully through the crucial stages of obtaining the regulatory & ethics committee approval, study initiation, monitoring and study close-out.

BCS does both site management and study/project management as well. Our trained clinical research coordinator (CRC) will assist the investigator and site staff with all day-to-day study activities. CRC plays a vital role in managing a clinical trial at the site level and acts as a link between the study sponsor, Ethics Committee and the Investigator Site.

Project Management
Excellence in clinical project management requires vision, understanding, adaptability, disciplined effort, and unrelenting focus on achieving goals. A strong plan at the beginning of the clinical study will prevent fatigue and chaos.

Preparation and planning is important to save time and money throughout a clinical trial. BCS Project Management ensures that all studies are carried out in full accordance with the study protocol, to agreed study timelines.

BCS assigns a Clinical Project Manager to each study to communicate and manage all study activities and act as the primary liaison to the Sponsor who communicates the client’s needs to the entire project team and plan the trial design, execution, strategize, set project team goals and timelines to align with the client’s expectations.

BCS Clinical Project Manager

• Assures study compliance with GCP and other regulations and guidelines.
• Maintains primary contact with the Sponsor and Identifies sponsor goals and objectives.
• Selects only those sites/investigators which are in agreement with the Sponsor.
• Selects and manages project team members (CRAs, as well as CTAs).
• Oversees study planning, implementation and close out throughout life cycle of study.
• Takes overall responsibility for all procedures and processes throughout the whole study period
• Manages and tracks Project timeline
• Establish lines and flow of communication with internal team members, the sponsor, and outside vendors.
• Establish agendas, organize and facilitates in person or online team meetings and communication (internal & external).
• Monitor study budgets and associated financial procedures.

Feasibility Studies and Site Management
Conducting clinical trial feasibility is one of the first steps in clinical trial. A thorough feasibility (An Investigator Interest Questionnaire) and site selection is the basis of any successful clinical trial. Our feasibility group has worked on virtually every therapeutic area. Our study feasibility assessment process is efficient and is capable of identifying the best investigative sites to conduct a clinical trial. Our custom designed feasibility questionnaires and tested processes are effective in predicting site success in implementing a given clinical trial.

Feasibility and selection of sites

• Maintaining Investigator database based on therapeutic area.
• Site infrastructure to meet study specification and regulatory authority
• Ethics committee CDSCO Registration, validity and meeting timelines
• Investigator’s qualification, interest, experience and prior ICH-GCP trainings.
• Availability of site staff with adequate qualification and experience (ICH-GCP trained).
• Previous experience in similar clinical studies.
• Trial-required facilities such as laboratories and pharmacies.
• Trial-specific equipment e.g. measuring and imaging.
• Site Recruitment Plan – unique for each site
• Patient retention Plan
• Additional sponsor requirements.

Clinical Site Monitoring
Our Clinical Research Associates (CRAs) are highly trained professionals who exercise ultimate efficiency in managing investigator sites. Lead CRAs are the primary point of contact between the CRAs and Project Manager (PM).

BCS develops Sponsor-approved monitoring plan for each study

Our Clinical Research Associates (CRAs) are highly trained professionals who exercise ultimate efficiency in managing investigator sites. Lead CRAs are the primary point of contact between the CRAs and Project Manager (PM).

Clinical Site Monitoring Services include

• Investigator Interest Questionnaire/Site Assessment Visit
• Pre-Site Selection Visit
• Investigator Meeting Planning and Presentation
• Study Initiation Visit
• Interim Monitoring Visit
• Serious Adverse Events
• Regulatory Document Preparation and Collection.
• Identification and Reporting of Protocol Deviations/Violations
• Corrective and Preventive Actions
• Close Out
• Site Termination
• Specialized Lab Audits
• Clinical Study Material Accountability

First monitoring visit will be scheduled based on the risk profile of the study. Subsequent monitoring visits will then take place as outlined in the Clinical Monitoring Plan.

Medical Monitoring
BCS has a dedicated medical monitor who is well qualified and experienced to monitor clinical trials 24/7. As required for a study or per sponsor’s requirements, customized medical monitoring services will be catered by BCS.

Clinical Data Management Services
Data management is essential in clinical development and it influences the quality of data received from investigative sites.

We will assist in:

• Subject Case Record Form management
• Data validation and review
• Data clarification forms (DCF’s)
• Edit checks and data queries
• Electronic data processing/reconciliation
• Data migration

Medical Writing and Translations
BCS undertakes medical writing activities, inclusive but not limited to, clinical trial protocol writing, designing Informed Consent Form (ICF), Investigator Brochure (IB), Case Record Forms (CRFs), Clinical Study Report (CSR). We also ensure the ICFs are translated into local languages by sub-contracting to language translation vendor.

Quality Assurance/Auditing
Needless to say, for trials undertaken by BCS, a dedicated QA team ensures excellent quality of the trial data at any given time. BCS also undertakes QA and auditing activities for studies (pre-clinical & clinical) executed at other sites or by other CROs.

Archival
Per various Regulatory Body requirements (US FDA, EMEA, CDSCO etc), archival of clinical trial related documents is mandatory throughout the duration of study and more importantly post completion of a study for a specified period of time. BCS provides archival services to all kinds of clients.