Solution for your research
- ArasClin is a profitable Canadian company, providing clinical research and pharmaceutical consulting to the pharmaceutical and biotech companies in North America, Australia and Middle East countries. It provides high quality service in regulatory, Clinical development, trial management and pharmacovigilance.
- Arasclin has provided and managed services directly or in partnership with other local Contract research Organizations for several clients; this ranging from multi-national pharmaceutical companies to small sized organizations.
- We have local team in Canada, Australia, Iran and UAE and trusted partner companies in Middle East which is a naïve and new emerging market for clinical research with large trials subjects.
- Now ArasClin provides the clinical research and regulatory consulting service for Middle East pharmaceutical companies to obtain EMEA and other country’s marketing authorization through expertise management team with several years’ experience in the global pharmaceutical and clinical research organizations.
- With local expertise and focus on quality, Arasclin ensures high quality clinical trial conduct and registration on time and within budget. We delivers both standalone services such as medical writing, consultancy, project management/monitoring, data management/biostatistics and full solution for clinical development.
Arasclin is a full-service provider, we offer end-to-end services to conduct clinical trials for your drug and we provide complete solution for clinical trials of any size, location and type, phase II-IV and we have significant experience in both pre-approval and post-approval trials.
Our Clinical Development team conducts clinical trials for pharmaceutical and biotech companies, maintaining the highest standards of ethics, quality and confidentiality. A team of well-trained professionals, experience in project management in various therapeutic areas.
We also offer complete solutions for Real-World Evidence (RWE) generation studies, PASS, product registries, disease registries, post marketing studies and Investigator Sponsored studies.
Skilled project management is the key to the success of any clinical trial.
Our project management team adheres to the highest standards of operational excellence and 'established industry best practices' to ensure high quality and on-time deliverables. With extensive regularly updated SOPs designed to ensure compliance to regulations, collaboration and project ownership, you can be rest assured that your project will lead to success.
Arasclin CRAs are an extension of you. Our CRA teams are locally hired and they are familiar with local culture, thus ensuring an efficient service that can resolve local barriers. We are sure you will agree that they are positive, professional, thorough, and articulate.
Clinical monitoring services include full-service monitoring, as well as risk-based and centralized monitoring services, depending upon your goals and the needs of your project. On average, Arasclin CRAs have over 4 years’ experience in clinical research.
Project management and Clinical monitoring team has the support of our dedicated medical monitors for different therapeutic area. Our medical monitors are professional Medical doctors with several years of experience in pharmaceutical medical positions.
The team responsibilities include detailed clinical study protocol review of inclusion/exclusion criteria, medication administration, lab tests and safety and review of CSR and manuscript.
Regular training to the project management and CRA team generate confident on the field. Our medical monitoring team helps the project stay on track and deliver quality.
Arasclin provides a full regulatory service. Our expertise will ensure that your studies meet Country-Specific regulations in all study stages. We have a database of country requirements, allowing us to forecast the start-up timelines. Arasclin can assist you to obtain the marketing authorisation in different countries.
Successful clinical trial relies on accurate and relevant data. Arasclin offers a full data management service. Clinical Data Management is performed by experienced teams and the clinical data managers, data associates and database developers have many years of experience in the pharmaceutical and life sciences industries.
Arasclin data management group offers services that include but not limited the following:
- EDC, paper and hybrid systems and processes
- Database design and validation
- Edit check programming and validation
- Double data entry (paper CRFs only)
- Query management
- Medical coding (MedDRA and WHO DD), SAE Reconciliation
- Management of external vendor data including central and local labs, imaging data, ePRO, ECG, biomarkers, PK/PD, etc.
- Data export
- EDC training for sites and the project team as well as EDC help desk services.
Data collected from trials and studies to support regulatory applications and submissions have to meet high standards for statistical design and analysis. Arasclin offers full biostatistics services for clinical trials and non-interventional studies and registries data analysis. Our statisticians have many years’ experience in providing statistical work for pharmaceutical companies.
Arasclin is able to provide sponsors with the following services:
- Study protocol design and other statistical consulting
- Sample size and power calculations
- blinded or unblinded interim analyses
- Case report form review
- Statistical Analysis Plans (SAP)
- Clinical trials analysis and reporting
- Adaptive and Sequential trials
- Data analyses, summaries, listings, and CRF tabulations
- Support for regulatory agency requests and meetings
- Database integration
- SDTM data set creation / conversion
- Safety Monitoring Boards (DSMB)
- Statistical input to the CSR.
- CDISC SDTM datasets ready for submission to the FDA.
A successful clinical trial must be supported by an extensive clinical research plan and documentation. Arasclin experts with significant experience in clinical research will help you to perform gap analysis and develop and implement your clinical strategies and clinical development plan.
Arasclin can provide the following documents which are all intensely assessed from a statistical, scientific, quality control and editorial standpoint:
- Clinical development plans
- Patient information leaflet
- Clinical study reports
- Clinical sections of common technical documents (CTDs)
- Clinical sections of new drug applications (NDAs)
- Written Subject Information and Informed consent forms
- Periodic safety update reports (PSURs)
- Data safety monitoring board (DSMB) manuals
- Medical and scientific literature reviews
- Abstracts, manuscripts, and journal articles
ArasClin’s executive management team worked for several years in the international pharmaceutical and European clinical research organizations in North America, Europe and Middle East and have rich experience in managing multinational clinical trials with highest international standards sponsored by world leading pharmaceutical companies.
Our clinical project management team consists of highly qualified specialists with medical, pharmaceutical background. The average experience of our employees in clinical trials project management is more than 7 years.
Arasclin is comprised of CRAs from around the world who are experienced in all aspects of clinical trial execution from feasibility assessments to study closeout and all steps in between.
Eighty five percent of our group have secondary educational degrees with some having achieved medical degrees or Ph.D.'s, education, an attainment that helps us uphold our corporate mission.
- Study design and methodology
- Good Clinical Practice for investigators
- Good Clinical Practice for Study Nurse and coordinators
- Project Management for Clinical Trials
- Documentation for clinical trial
- Safety reporting principals
We are committed to provide high quality service and on-time delivery to support the pharmaceutical and biotechnology companies to bring new and innovative medicine to patients sooner.
Arasclin always hires the best. Whether you’re a professional in clinical research, medical writing, pharmacovigilance or data management or a new graduate, Arasclin has challenging career opportunities that may interest you.
Please post your resume to firstname.lastname@example.org for current or potential future opportunities.