ABIOGENESIS CLINPHARM

AXIS Clinicals Limited is one of the most experienced and fastest growing Clinical Research Organization.

Our state-of-the-art facilities houses 500+ dedicated full-time professionals to ensure the quick turn around time with high quality. Our facilities are accredited by DCGI (Drugs Controller General – India), NABL (National Accreditation Board for Testing and Calibration Laboratories - ISO 15189:2003) and inspected by US-FDA, UK-MHRA, Brazil-ANVISA, France –AFSSAPS / ANSM, GCC, MCC-South Africa etc.

Within short span, we have achieved the milestone of completing 2750+ clinical studies and 1000+ product approvals from various regulatory agencies.

65+ regulatory audits from global competent authorities is testament to our professionalism and dedication to quality studies.

Our Phase II – IV capabilities are growing along with an extended portfolio of Site Management, Medical Writing, and Data Management.

CliniRx is a global Clinical Research Organisation with deep regional experience. CliniRx offers ICH-GCP compliant clinical trial services from Phase I – IV in key therapeutic areas to support clinical development requirements. We have offices and operational capabilities in India, US and UK.

We offer end to end services starting from conduct of Feasibility Studies, Study Planning to Regulatory Submissions, Site Evaluation and Selection, Site Monitoring, Project Management, Medical Monitoring, Pharmacovigilance, Clinical Data Management, Data Analysis, Medical Writing and Quality Assurance.

COMPANY
Monitor CRO was founded in İstanbul (1999), as a pioneering Contract Research Organization in Turkey. We are currently the leading, most experienced and dedicated CRO with a 100+ full-time personnel with on-going monitoring activities for various international and national studies.
CLINICAL TRIALS & CONSULTANCY SERVICES
MEDICAL CONSULTANCY
• Clinical trial planning and design
• Recommendations for future studies/development
• Regulatory strategy identification
TRAINING
• Basic medical training
• Clinical trials trainings
• Good Clinical Practice (GCP) training for study monitors, investigators, research staff and site coordinators
MEDICAL WRITING AND SUBMISSION
• Protocols
• Case Report Forms
• Abstracts
• Trial documentation and archiving
• CRF, eCRF and ICF translations into local language and adaptation to local requirements
• Study reporting in line with ICH-GCP requirements
• Study Design and creation of Study Synopsis
• Manuscript writing
DATABASE MANAGEMENT
• Database Design
• Data Collection and Entry
• Drafting and Finalization of Data Management Plans
• Data Validation Cleaning and Query Writing and Handling
• Electronic Data Handling
• Medical Dictionary Management and Medical Coding
• SAE Reconciliation
• Quality Controls
• Statistical Analysis
PROJECT MANAGEMENT
• Observation
• Bioequivalence
• Phase I, Phase II, Phase III
REGULATORY AUTHORITY APPLICATIONS AND APPROVALS
• Initial Application, preparation for Ethics Committee
• Initial application file preparation for Regulatory approval
• Follow-up of applications
• Preparation of files for regulatory and administrative changes during study
• Pharmacovigilance reporting to EC’s and Regulatory Authority
• Applications to RA for site coordinators
• Institutional review board
SITE OPERATIONS
• Site selection and feasibility
• Site contracts and agreements
• Site monitoring
• Site coordinator outsourcing
PHARMACOVIGILANCE SERVICES

CONTRACT RESEARCH ORGANIZATION

Norwich Clinical Services is a global Contract Research Organization (CRO) providing Clinical Research, Bioanalytical, Pharmacovigilance and Training Services.

The CRO is headquartered in Bangalore, INDIA and the leadership team have deep insight, knowledge and experience in the conduct of Bioavailability/Bioequivalence (BABE) studies, Clinical Research - Phase I-IV, Pharmacovigilance and Training services.

The NCS PV team manages >750 Molecules for the US, Europe, and APAC. We have call centers in the US and India.

Our facilities have been inspected by most global regulatory agencies such as FDA, WHO, ANVISA, MOH Turkey, EMA, DCGI and NPRA.

All our services are conducted in strict conformity with the latest GCP, GLP and 21 CFR (part 11) and all other applicable guidances.

We have state–of-the-art facilities, and exceptional expertise to conduct Phase I, II and III studies, bioavailability and bioequivalence studies, pharmacokinetic studies in patients & healthy subjects, drug metabolism studies, dose proportionality studies, multiple dose studies and clinical developmental programs. Our team has considerable experience in various dosage forms including parenterals, suspensions, topical preparations and delayed release formulations.

We combine comprehensive services and exceptional customer focus to offer a complete range of Clinical, Bioanalytical, Pharmacovigilance and Training Services.

Norwich Clinical Services is a Lotus Pharmaceuticals Company.

Mission statement:
Norwich Clinical Services is committed to maximizing customer satisfaction and strives to achieve the goal of excellence, through a continual improvement of our processes, systems and services, in delivering high quality projects meeting regulatory requirements in full compliance with GCP, GLP and all applicable good practices in a timely manner.

All levels of the organization are dedicated to the process of exceeding customer requirements

The preclinical research division of Shin Nippon Biomedical Laboratories, Ltd. (SNBL) is Japan’s largest and oldest preclinical CRO. For over 50 years, we have been able to balance speed with superior quality, because we understand just how important timelines are to our clients. SNBL’s experience and quality are valued by both our Japanese and global clients, and the GLP reports we have produced have been an integral part of submissions to regulatory authorities including the FDA, MHLW, and EMA.

Our services include general toxicity, reproductive and developmental toxicity, safety pharmacology, genotoxicity, specific toxicity, and bioanalysis studies, as well as efficacy models. We have a stand-alone Pharmacokinetics and Bioanalysis Center which meets the clinical and preclinical bioanalysis needs of our clients.

Contact us at info@snbl.co.jp today to discuss how we can meet your safety and efficacy drug development needs.