Evolution Of Bio Clinical Laboratories

With the changes and evolution in the medical and clinical landscape, there came upon a well defined role for supervisors, directors, technologists, consultants in the Clinical Laboratory Improvement Amendment of 1988. This act got enforced in order to indicate the training, qualifications and the certifications that might be essential for any more willing to make a career in the domain of bio-clinical laboratory. However, there have been several signs that the need for qualification as a laboratory professional in the forthcoming days might be minimized to a stage that will be unlikely to commensurate with the high - end practice.

Though this remains, just an observations eminent clinical research organization (CRO) in India has been focusing on improving the conditions of their bio-clinical laboratories, that in most cases acts as a Central Laboratory. It forms the very nucleus of medical studies, clinical trial, experiments and multiple external proficiency testing programs with national and global laboratories to retain excellent levels of quality control.

Standard to high-end bio clinical laboratories of famous CRO’s are generally equipped with state-of-the-art infrastructure, a wide selection of high-end devices and immaculate logistics. This apart, the most crucial element in a bio clinical laboratory are its well trained and experienced medical technicians, who are supported by innovative technologies in the new age Laboratory Information Management Systems (LIMS) for transferring online data, guaranteeing shorter turnaround time with high levels of quality and reliable services. Simultaneously, the bio clinical laboratories today are completely equipped to conduct a wide range of investigations that comprise the following:

• Hematology
• Urine Analysis
• Coagulation Studies
• Biochemistry
• Clinical Pathology
• Endocrinology
• Serology
• Inflammatory/Immune markers
• Infectious Disease Markers
• Therapeutic Drug Monitoring
• Tumor Markers
• Lipid Profile
• Liver Function Test
• Anemia Profile
• Renal Profile
• Diabetic Profile
• Biomarkers
• Capabilities for other tests

The rise of health care expenses over the past few years has been the very basis of high revenue for both medical institution and bio clinical laboratories. While the state of reimbursement retained a sufficient differential over the operating expenses, the situation was one embraced by hospital administration and by operators of independent bio clinical laboratories. On the other hand the increasing percentage of human ailments propelled the medical professionals and institutes to bring about radical changes in the bio clinical laboratories so that it can help in discovering innovative treatment methods and come up with better drug development processes.

Read More About: Clinical Pharmacokinetic

Role Of Bio Clinical Laboratories In Clinical Trials

Recently the pace of medical researches and clinical trials has increased its prominence. As a result of which, today the need to modernize the medical laboratories and equip them with advanced and modern infrastructure and other high-end medical equipments has also increased. A medical professional utilizes a bio clinical laboratory for studying, researching and analyzing cells and other body fluids. Similarly, few other procedures such as detecting parasites, bacteria and other related microorganisms, medical tests to evaluate the drug levels present in the blood and the like are also conducted. This apart, they also review the manner in which the patient responds to a certain treatment method.

Therefore, it can be said that bio clinical laboratories form the nucleus of all important disease diagnoses, treatments and drug development. Leading clinical research organizations (CRO) in India today are well equipped with bio clinical laboratories that have their own state-of-the-art infrastructure that assist in regulatory services, clinical trials and other important research work. Furthermore, clinical technicians are always supported by advanced technology that consists of Laboratory Information Management Systems for all sorts of online data sharing. This in turn makes sure that there are lesser turnaround times and a high-level of consistency and quality.

In addition to all this, a bio clinical laboratory comprises of the samples that are prepared and evaluated by expert medical technicians. It has been used to research in cells and detect any type of cell complexity or abnormality in an individual’s body. High-end medical devices for instance cell counters; microscope and many others are used by clinical technicians. Furthermore, there are other advanced computerized equipments that are also utilized to evaluate the medical processes.

Leading CRO’s in India have their own bio clinical laboratories that apart from clinical trials help in carrying out investigations and multiple medical processes. Some of them are listed below:

• Hematology
• Urine Analysis
• Coagulation Studies
• Biochemistry
• Clinical Pathology
• Endocrinology
• Serology
• Inflammatory/Immune markers
• Infectious Disease Markers
• Therapeutic Drug Monitoring
• Tumor Markers
• Lipid Profile
• Liver Function Test
• Anemia Profile
• Renal Profile
• Diabetic Profile
• Biomarkers
• Capabilities for other tests
  

A bio clinical laboratory assists the medical students and their studies with which can arrive at and introduce scientific medical theories, analogies and drug development processes.

Read More About: Clinical Pharmacokinetic, biometrics

Regulatory Services Offered By Indian CRO’s

India over the last decade has come up with various developments and advancements in medical trials and in project and data management. India has been successfully able to provide cost savings of 50 to 60 percent in clinical trails. With the research discovery acquiring approximately one-third of the R&D expenses of the western medical industry, outsourcing to lesser expense countries is a wise move. With the financial and regulatory pressure expanding in the US and European medical industry, it is estimated to propel the development in the Indian clinical trials market.

All this has compelled the clinical research organizations (CRO) in India to introduce advanced clinical laboratory services that assist in disease treatment and drug development. The medical doctors and technicians’ research experiment and conduct different medical studies and experiments and review human blood sample and assesses blood samples and evaluate the impact of drugs on the blood. This apart, the CRO’s also give importance to regulatory compliance services and appropriate quality assurance. There is a separate team for regulatory services and audit compliance that is in turn supported by a vast knowledge of the local regulatory procedures and helpful associations with various regulatory agencies ensuring perfection in the clinical trial approval process.

Renowned Indian CRO’s specializing in regulatory services has completed various audits from multiple global and Indian regulatory agencies. Simultaneously, there have been study submissions from multiple countries. The vast range of regulatory services offered includes the following:

• Formulating regulatory strategies
• Replying regulatory agency queries
• Renewing Import License
• Procuring drug import licenses
• Follow-up and submissions on the application
• Tracking applications and approvals
• Submission of Clinical Safety Report (CSR)
• Safety Reporting
• Procuring NOC for export of biological samples
• Compiling a clinical trial application

In addition to that, with regards to QA Indian CRO’ s have a complete quality assurance team to manage the same with a standard quality. The team focuses on quality that permeates through the processes within the domain of each single process. In addition to that, there are thorough implementations that are carried out by the Quality Assurance and Quality Control processes. QA practices span across Bioanalytical, Clinical, Statistics, Internal Audits and Reporting by the QA team for area specific SOP compliance. Simultaneously, there are other in-house capacities that CRO’s perform and includes of components such as Site Audits, Vendor Audits, Process/System Audits, and Document Audits that includes protocol, clinical study reports and important clinical trial documents.