ClinAsia

Every human on the basis of his interests, passions and opportunities available define their careers which they strive to make it successful and useful to the society. There has been a series of promises in and around the career of a person or a team. Each career has a different set of characteristics associated with it. Some career call in for high amount of patience and few others call in absolute alertness while some others call for the on the move profession.

A career in clinical trials is something which has been termed to be very special. It is termed to be special as it does not call for any special characteristic; rather it calls for a combination of characteristics as the people opting for this career are always accurate and appropriate in all disciplines. Experts in Clinical trials industry are responsible for the activity with in their own area of specialization and are made accountable for those activities.

An expert always needs to be at his best as his activity is the source for some other activity with in clinical trials. Hence a small error by anyone in the entire process may show an adverse effect on the entire process of Clinical Trials. Hence a career in Clinical Trials calls in for a huge commitment and the highest level of professionalism and accuracy.

The entire concept of Clinical trials is mostly concerned about Quality and Efficacy. This is the gateway of success for clinical trials. Given such high standards, the industry at present is facing a shortage of experts. Sighting this shortage of experts, globally many educational institutes have come up in numbers offering expert courses and suggestions to make interested students as the assets of this industry for the future.

However the students who come from such institutes with good theoretical knowledge needs to be trained properly with industry expertise to make them fit the industry standards and requirements Many Clinical Research Organizations like ClinAsia offers excellent training in this regard to fill in the gap from college to corporate. This training provides excellent opportunities for people to fit directly into the industry standards and requirements.

ClinAsia possess a huge availability of experts and associates related to various therapeutic areas and various designations in the clinical trials process. ClinAsia can also help the most in patient recruiting and other related activities.

http://www.clinasia.com/

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.

www.clinasia.com

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/

Therapeutics

When you think outsource your drug development clinical project, you think of the one who can stand up for you and deliver. At ClinAsia it is ensured that you shall feel us as an extension of your own team.

Our task on hand is to drill down in to our expert resources and ensure driving your project successfully on time with a value addition. Superior solutions, proactive service and a personal approach are the trademarks of ClinAsia which makes it as the most preferred partner to many clients in Asia and globally.

It is most important and necessary that you work with a clinical research organization that has highly organized expertise in clinical development and has the most critical clinical and therapeutic expertise to meet your requirements and expectations. At ClinAsia we have a significant range of local and global therapeutic expertise, and in many therapeutic areas ClinAsia knowledge is second to none.

ClinAsia specializes in the following Therapeutic areas:

• Cardiovascular
• Oncology
• Central Nervous System
• Dermatology
• Immunology
• Hermatology
• Opthalmology
• Pediatrics
• Urology
• Respiratory
• General Medicine
  
  

PreClincal Services

PreClinical Services

ClinAsia daily schedule consists of developing programs to provide correct information about the chemical making of a new drug, its safety, its formulation strategy and its administration procedure to be followed when provided to the first man.

Using past data about the chemical making, we help our customers create an effective regulatory strategy formulation for good laboratory practice, toxicology and metabolism clinical studies required to support first-human studies.

Non-Clinical Development Program

Previously made development programs to avoid early chemical complexities in Clinical Trials.

Preclinical Estimation

Our experts at ClinAsia provide a complete range of research services to clients to select the most suitable study design and additional screening method for an investigational agent and there by maintaining the Preclinical estimation.

Chemistry, Manufacturing and Controls Consulting

Taking into account our customers manufacturing facilities, ClinAsia provides regulatory guidance to suit specifications, method creation and validation as well as co-coordinating stability studies.

Pharmacology and Toxicology

ClinAsia has extensive expertise in pharmacology with preclinical efficiency, efficacy, General Toxicology, Special Toxicology, Genetic Toxicology, reproductive and development toxicology, Safety pharmacology to guide clients through the preclinical phase.

Regulatory Submissions

ClinAsia has extensive experience preparing all major regulatory submissions, including complex multinational submissions for any type of drug applications.

www.clinasia.com

Clinical Data Integration

Data integration, known in the pharmaceutical world as ISS (Integrated Summary of Safety)and ISE (Integrated Summary of Efficacy), is a multi- latitudinal task, and is well recognized for its tediousness and time-consumption. Therefore, it is desirable to automate such a time-consuming task so that a routine process can be developed. Is this wish realistic or achievable to a certain degree?

Research data usually come from multiple sources. An epidemiology study may use historical controls from different time periods and geographic locations in a case-control study. A health economist may want to combine physician data from the AMA database with those of a company’s database.

In a typical clinical study, data may come from different trial sites, especially from international sites, from different labs, or from parallel protocols.Furthermore, for the convenience of analysis, statistical analysts in a multi-protocol study may create their own derived variables or flags for their own individual protocol, which are usually not communicable to each other across protocols

This system tries Data from different sources are rarely the same. In many circumstances, therefore, data integration is an essential step fo r standardized, consistent, and homogeneous reporting. Integration is in fact the process that uniforms different data sets so that they can be pooled together. Because the process is typically done manually, it is tedious, time-consuming, and can easily frustrate or overwhelm the most experienced programmers by the detailed attention and the large amount of home work.

Is there anything that can be done to reduce such a workload? Being aware of a lack of sucha technical tool for data integration in the industry, Kindly share your inputs in regards to this.

www.clinasia.com