The clinical trial company

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

Our expertise covers a wide variety of countries across the world.

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