The CLINICAL TRIAL Company™
Putting you on the path to success
The CLINICAL TRIAL Company™ is the full service division of TCTC Group™, specialising in clinical studies for pharmaceutical, biotechnology and medical device companies. Our clinical trial development processes facilitate commercial efficiency and cost effectiveness in helping bring clients’ products to market. We are used to working with clients who have to be efficient with their resources. TCTC are flexible in working in changing environments and are able to manage your clinical programme from concept, through to marketing application if required.
Our success is achieved through recruitment and development of high calibre staff. Customer loyalty is also an important factor in our success. All of our sponsors have awarded TCTC repeat business and/ or recommended us to other organisations.
TCTC has a wide range of therapeutic area expertise and all of our personnel have direct, hands on experience of Clinical Trials and ICH GCP with the ability to provide a real world insight into the role.
Our Services
Cutting edge solutions tailored to your needs
Project Management
Project needs assessment and contingency planning
Overall project planning and communication planning
Resource allocation and team management
Risk assessment, tracking and management
Budget development and tracking
Management of project timelines, teams and deliverables
Clinical Trial documentation preparation
Design/review/translation of:
Protocol
Investigator Brochure
Master Informed Consent Form
CRF
Pharmacy Manual
Operations Manual
Clinical Monitoring Plan
TMF set up and management
Clinical Monitoring and Site Management
Feasibility
Site identification and Qualification
Investigator Site Set up and Initiation
Recruitment planning and tracking
IMP Management
Routine Monitoring visits
Site Management
Motivational Visits
Site Audits
Resolutions and responses to queries
Site close out visits
Pharmacovigilance
Development and maintenance of database
Preparation of case narratives
Expedited SUSAR reporting
Query resolution to case closure
Medical Coding
Development of DSUR
Other
Pre-Clinical Development
Clinical Trial Packaging
Central Lab Management
Contract Preparation and negotiation
Quality Management System and auditing services
Internal and external audits (GCP, GLP, GPvP and GMP)
Statutory GCP and GMP preparation and inspection (FDA, EMEA, MHRA)
Quality Management System development
Review of quality systems and legacy operations
Standard Operating Procedure evaluation and generation
Process mapping
Documentation management
Staff training
QP services
Data Management
CRF Completion guidelines
CRF Tracking
Database design
Data entry/ editing/verification
Data Coding
Reconciliation of SAEs
Medical Review of CRF's
Management of external imports
Database lock
Statistical Analysis
SAP development
Programme listings, figures, tables
Final analysis & Statistical Report
Regulatory Consultancy
Regulatory Submissions
Ethics Submissions
CSR preparation
Protocol & CSR Synopsis preparation
Manuscripts preparation for publication
Medical Monitoring
Medical Monitoring 24/7 cover
Medical assessment of subject eligibility
Medical review of data listings
Therapeutic area training
Protocol and project-specific safety training at investigators meetings
Study document review (IB, protocol, CRF, ICF, study manual and SAP)
Geographical Experience
