Services

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.

Medical Monitoring 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.

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
• Protocols
• 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 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 authorization in different countries.