admin / 29th July, 2016

CLINICAL TRIAL

Insight

Drug, Biological,

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Summary:

It is acknowledged within the pharmaceutical industry that clinical trials represent the single most expensive aspect of a drug, or treatment, development process.

It is acknowledged within the pharmaceutical industry that clinical trials represent the single most expensive aspect of a drug, or treatment, development process. Specifically, clinical trials are enormously resource-intensive and involve repetitive, often tedious, studies for the collection, analysis and verification of data.So it is vital that such trials or studies are managed with the utmost care and attention. Clinical trials require careful planning at each and every stage to ensure the generation of clean and accurate data, and this can only be achieved if it is managed by highly trained professionals.As part of the drug development process, outsourcing clinical trials management to CliniExperts will be highly cost effective for the small to mid-size pharma, biotech or device company.We handle all aspects of the clinical trials management process on behalf of the client including:

Site Selection

Its selection is assessed on expert analysis of the site based on the Site Attractiveness Index (SAI). The SAI is calculated based on subject recruitment potential, PI experience, trained site staff, etc. As a result, study targets and time lines are assured.

Monitoring Services

Monitors are highly experienced and professionally trained by our auditors, thereby ensuring their monitoring capabilities.

Safety Monitoring Services

Our medical monitors have many years of industry experience reviewing and reporting on safety in clinical trials.

Project Management Services

Our project managers, and specialists, are able to monitor the project and study site performance while the trials are progressing.

Data Management Services and Case Study Reporting (CSR)

We offer a range of services covering Case Report Form (CRF) designing, database creation and database lock, and statistical analysis and medical report writing.Our data management systems are easily customizable to meet specific trial demands and budget constraints. Our goal is to provide a fast, efficient, high quality service at competitive prices.

BA/BE Services

Various services related to bioavailability, bioequivalence and pharmacokinetics are undertaken in strict compliance with international regulatory requirements, and scrupulously monitored by our quality assurance professionals.

Post Marketing Surveillance/Phase IV Studies

We are able to undertake in-depth, post marketing surveillance observational studies in all therapeutic indications. The services include:

Protocol writing
CRF designing
Investigator selection
Patient enrolment
CRF evaluation
Report writing

“The direct involvement of people is unavoidable. CliniExperts has designed and implemented policies and procedures to ensure that the basic principles of ethics – ensuring the rights, safety and well-being of the people involved in a clinical trial – are preserved.” (Dr Ashwini Kumar, on CliniExperts ethics)

Tags CDSCO Ethics Committee