CliniRx

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

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.

TRIUMPHARMA was founded in 2002 , is a full service CRO that supports the pharmaceutical and the biotech industries in introducing new solutions to the pharmaceutical markets, with core strength in :
Clinical Trials [Phase I - Phase IV] including Clinical Data Management and BE/BA studies.

Over the years we have successfully conducted more than 300+ US-FDA submissions , EU/ANSAM/Bfarm/MHRA submissions (NDAs & ANDAs) and MENA/JFDA submissions, using HVs and patients in various therapeutic areas such as CV diseases, Gastro-intestinal disorders, Respiratory/Pulmonary disorders, Metabolic disorders, Endocrinology, Nephrology/Hepatology, Rheumatoid Arthritis Disorders of immune systems, Neurology/Psychiatry, Gynecology, Acute/Chronic infections and Oncology.

TRIUMPHARMA has experience in many of the POC indications, in addition to our experience in early phase studies such as Asthma, NASH, Parkinson, AF, Diabetes, and others. We have also conducted many studies on monoclonal antibodies including HAE and biosimilar /biotech products.

TRIUMPHARMA encompass a total bed capacity of 80 beds across our two floors ((over 200 beds with our hospital sites) and 5 LC/MS/MS machines. We have a dedicated facility and team for Phase I-IV clinical trials conducted in compliance with ICH GCP guidelines. And we have our own diagnostic and screening medical lab, Bioanalytical lab with state of the arts LC/MS/MS equipment’s, the trained PIs, Research Nurses, CRCs, CRAs, Project Management, certified and trained Spirometer technicians, dedicated Data Entry team with familiarity with the relevant and most updated clinical software’s used in trials, Qualified site and IMPs Depot .We are also able to offer our clients the benefit of a large collective experience when formulating and implementing regulatory strategies and study designs.

We have successfully been inspected by US-FDA , EMA, French Ministry of Health-ANSM, German Ministry of Health- Bfarm, Turkish MOH, GCC, UAE MOH, JFDA,

Abiogenesis Clinpharm Private Limited is an emerging contract research organization (CRO) that provides client specific services in clinical development of drugs and devices. Our research wing helps clients in clinical development program of drugs and devices at every step. Our expertise comes from an experienced team of professionals having credentials of successfully conducting national and international clinical trials across all phases of clinical development. Abiogenesis Clinpharm Private Limited is capable of delivering quality work from early proof of concept to late phase development including post launch product lifecycle management.

We are a team of highly skilled people having expertise in the area of clinical research and work experience in leading clinical development programs of many reputed organizations. Our team epitomise scientific knowledge and operational excellence in clinical research industry. We have the ability to integrate the primary concept of clinical development into project management plan with micro level execution strategies. We have direct operating experience from initial planning to project execution from Phase I to Phase IV studies in different therapeutic areas across the globe. Our expertise should be utilised in following services.

• Clinical Operation
• Biometrics
• Regulatory Affairs
• Medical Affairs
• Quality Assurance
• Pharmacovigilance