Phase IV Services

ClinAsia clinical experience in product development ensures collaboration and integration from pre-approval to post-approval. We provide a custom-tailored process, fine-tuned across the globe, to meet local regulatory requirements. Our operational model is based on a robust technology platform to support remote centralized management of our clients' sites, and our operating procedures are designed for a post-approval setting.

Early Post-Approval Planning

ClinAsia team helps its client in post approval planning in manufacturing and go to market strategies.

Product Safety and Pharmacovigilance

The team has extensive experience in the collection of safety information for more than 100 products, covering a broad spectrum of therapeutic areas.

Late Stage Research Services

ClinAsia team has helped clients develop and implement late-stage research, including registries and observational studies for more than 10 years.

Registries and Observational Studies

ClinAsia can help in maintaining registries and conduct observational studies once the product has been approved.

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Phase II-IIIb Services

We at ClinAsia advance a product through development and approval on time and within a client's budget. Our experienced teams deliver quality results for our clients' drug development needs.Development ConsultingOur strategic product development solutions offer our clients the best long-term strategies for their products.

We help our clients reach key milestones in a timely and cost-effective way while minimizing risks by designing, planning and implementing high quality, strategic product development programs.

Data Management

ClinAsia provides data management expertise and comprehensive data management services for Phase I-IV clinical trials. The data management planning process emphasizes close communication with the sponsor through all phases of development and review of database specifications.

Quality Assurance

ClinAsia staff is accessible and responsive to questions and requests for information during any part of a study. We provide an independent assessment of the client's quality assurance procedures, based on Good Clinical Practices, regulatory requirements in drug development projects.

Project Management

Our project team ensures deliverables on-time and on-cost, resulting in effective Phase programs. Your people will be fully trained in the therapeutic area being studied and possess a remarkable ability to anticipate risks and finish of the study on a clearly visible success note.

Clinical Monitoring

As always our clinical monitoring teams deliver quality, timely results. Counting by therapeutic industry experience with which ClinAsia provides consistent, effective and interactive dialogue at the sites.

Safety and Pharmacovigilance

Through our customized safety plan we provide comprehensive safety coverage round the clock. We ensure safety by maintaining clinical safety databases, effective monitoring through coordination of data monitoring committees and also using effective alerting system which is automated with a signal alarming system.

Patient Recruitment

Effectively designed programs help ensure that ClinAsia will generate the calls needed to meet your enrollment targets.

Biostatistics

We provide biostatistics consultation, programming, and analyses. Software used includes SAS, StatXact, nQuery Advisor, and other cutting-edge products.

Regulatory Affairs

ClinAsia ’s regulatory affairs staff provides flexible and responsive services according to your needs, ClinAsia regulatory affairs team assists you in meetings with regulatory authorities provide scientific advice and define a regulatory strategy.

www.clinasia.com

Phase 1 Services

ClinAsia Phase I services is treated as one of the best in the world with the proven ability to carry out multiple studies in parallel, and our services span over from healthy volunteer clinics to regulatory affairs. ClinAsia ability to successfully facilitate large trials along with our committed, experienced experts enables effective planning strategy and implementation for the first phase of clinical trials.

Research Clinic

Created specially to enhance first-phase trials, ClinAsia research clinic has a huge range of specialized technology facility for storing and handling, administering and monitoring new drugs being planned for development. Taking into account the clinical expertise ClinAsia possess ClinAsia deals with the studies such as First Administration into human, Bioequivalence, Bioavailability, Ascending dose safety, Drug interaction at macro level.

Clinical Monitoring

ClinAsia expert trained Associates ensure the ultimate quality review of data and improved interaction with study sites. ClinAsia clinical research associates during their monitoring makes sure to see over data collection, view source documentation, case report forms, regulatory compliance, solve data queries and implement interim analyses.

Project management

ClinAsia from its vast experience in the past learns that project manager is the captain made responsible for the successful functioning of a trial and it’s his responsibility to ensure that the project is on time and on budget. ClinAsia assigns one of our super senior experts and shall be made a point of responsibility as well as a point of contact for all future interactions till the close of the study.

Data Management

ClinAsia provides data management expertise and comprehensive data management services for all phases of clinical trials. The data management planning process symbolizes regular communication with the sponsor through every phase of development and review database specifications. Quality control mechanisms monitor every element of the data management process, and ClinAsia helps minimize the client’s technology investment through guidance in the most effective use of appropriate technology according to the sponsor’s particular needs and preferences.

Biostatistics

ClinAsia provides biostatistician consultation, analyses and programming. Software which would be for this purpose includes SAS, StatXact, nQuery Advisor, and other leading marketing edge products.

Pharmacovigilance

Through ClinAsia customizable safety plan we provide efficient safety coverage round the clock. ClinAsia ensures safety by effective monitoring through coordination of data monitoring committees, maintaining clinical safety databases and also using innovative alerting system which is automated with a alarming system.

Regulatory Services

ClinAsia ’s regulatory affairs staff provides flexible and responsive services according to your needs, ClinAsia regulatory affairs team assists you in meetings with regulatory authorities provide scientific advice and define a regulatory strategy

http://www.clinasia.com/