Catalyst Clinical Services Pvt. Ltd.

ACROSS is the first truly global, agile CRO alliance. Offering cost effective, cutting edge innovative solutions for small/medium pharmaceutical and biotech companies as well as public health institutes and non-governmental organizations, ACROSS is the latest player on the global field of clinical trials.

ACROSS Global is an entirely new business model, providing enhanced and innovative global solutions through highly qualified, globally experienced, knowledgeable local experts. ACROSS Global identifies, analyses and mitigates risks across the entire clinical research spectrum, with an agility and focus to the envy of competitors. We provide value added solutions individually tailored for small and mid-size companies.

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

Founded in 1984 with headquarters in Hyderabad, India, VIMTA LABS LTD., is a leading contract research and testing organization, providing bio/pharmaceutical companies an integrated scientific, technical and regulatory expertise to support all stages of drug development and manufacturing process. Our service portfolio includes preclinical and clinical research; and cGMP laboratory services viz., method development, microbiology, stability testing, extractables & leachables, process validation, quality control, physical characterization etc.

In our 34 years of journey, we have gained in-depth scientific and technical expertise through working with a variety of molecules and formulations in different therapeutic areas. We support the needs of more than 300 bio/pharmaceutical companies across the globe, from virtual to large pharma and biopharma through a wide range of expertise. Our team of 1000+ professionals constantly endeavor to provide timely scientific solutions and services to help customers manage their drug development and manufacturing processes more efficiently, without compromising on quality.

We have a track record of strict compliance to regulatory requirements (cGMP, GLP, GCP) and Standards (ISO 17025, ISO 15189, ISO 9001), and have undergone over 40 regulatory audits successfully from regulatory agencies across the globe including DCGI, NGCMA, USFDA, WHO, MHRA, ANSM, ANVISA, BfArM and DRAs of Denmark, Sweden, Portugal and Ukraine.