For over a decade, ClinTec International has provided high quality services to the pharmaceutical, biotechnology and medical device industries and has managed over 250 projects worldwide. With continual pressures upon the industry to increase development capacity without increased fixed costs, in addition to time-to-market pressures, development activities are being increasingly outsourced.
Available separately or as part of a full service program, our Clinical Research services cover a broad spectrum of activities from protocol development and site identification/evaluation through to delivery of the final clinical study report. With ClinTec you can be reassured of high quality service and results that are delivered on time and within budget.
Our Services in Clinical Operations
Feasibility studies: Our experienced feasibility teams have a proven track record in making the correct site selections in advance of study execution
Essential document development and associated activities: From Study Synopsis to protocol to Clinical Study Report, Patient Informed Consent Form, Investigator Brochure, Case Report Form and EC/CTA submissions.
Monitoring: Our CRAs are trained to international standards to be able to give full support to sites. We have a large pool of experienced CRAs all over the world in many geographically diverse regions that can be assigned to your project within a short time frame.
Project management: Highly motivated Project Managers with broad therapeutic knowledge and experience across all phases of a clinical trial will be your single point of contact for the management of your trial.
International Regulatory Affairs: Our team of Regulatory Affairs professionals has extensive experience across the full range of regulatory procedures and is highly skilled in interfacing with Regulatory Agencies. We ensure high quality, compliance with regulatory requirements and on time delivery, to guarantee that your clinical trial is started as fast as possible.
Quality Assurance: Our QA professionals will ensure the quality of study deliverables.
Patient Recruitment: Our local recruitment specialists are able to provide tailored recruitment support packages to help sites cope with the challenges often faced in reaching recruitment targets. Services include but not limited to recruitment planning, advertisement coordination and placement, patient outreach, referral programs and study awareness activities.
Drug Safety: Our professionals will ensure that the safety reporting will meet all local and regulatory requirements.
Our Experience:
Over 250 projects worldwide With coverage in over 40 countries we are able to meet the challenges of the clinical research industry, achieving rapid regulatory approval, high patient recruitment rate and cost efficiencies. We easily draw resources and expertise from anywhere in the ClinTec world to ensure that the most appropriate people are working quickly and effectively on your project, achieving cost savings and efficiency in the process. Clinical studies have been conducted in all main therapeutic areas, in particular Oncology, Cardiovascular, Neurology, Immunology and Rheumatology.
Our Clinical Research Personnel:
ClinTec has access to a large clinical research resource pool spanning 80 countries including specialists throughout the world and in many diverse regions. Our range of clinical professionals includes Project Managers, Project Management Assistants, CRAs, CTAs, Data Managers, Medical Advisors, Medical Writers, Quality Assurance professionals and Auditors.
Our Services in Clinical Consultancy:
Strategic Planning: identifies the optimal strategy for the development of our client’s drug portfolio. Regulatory consulting: Ongoing advice and support to reach IND, EMEA approval and provide regulatory intelligence. Quality Assurance Consultancy ICH GCP Training Programs Medical Writing: We have an experienced team able to provide full support in high quality document and publication development.
Our Services in Global Clinical Resourcing:
Flexible resourcing model by which ClinTec staff can be in-sourced to Client programs in any region of the world at competitive rates.
ClinTec focuses on supporting clients in all or any aspect of their clinical drug development projects to accelerate drug development without compromising on quality
ClinTec has developed in many emerging markets while in parallel continuing to invest in established countries
ClinTecs’ Global Coverage
Europe / USA and Canada / Latin America / Asia Pacific / Middle East, Gulf States and North Africa / Central and South Africa / India / South East Asia
