FAQs

Clinical research is a branch of medical science that determines the safety and effectiveness of medications, devices, diagnostic products, and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relief of symptoms in a disease.

Pharmaceutical products are bioequivalent if they are pharmaceutically equivalent or pharmaceutical alternatives, and they display comparable bioavailability, when studied under similar experimental conditions. Bioequivalence is considered proven, in case the bioavailability, in terms of peak (Cmax and Tmax) and total exposure (area under the curve (AUC)) after administration of the same molar dose under the same conditions, are similar to such a degree that the effects of the studied products can be expected to be essentially the same.

Bioavailability is the degree to which, or the rate at which, a medication or other substance is absorbed or becomes available at the targeted place in the body. Bioavailability can be influenced by inactive ingredients in the drug such as additives that prevent the medication from dissolving in the stomach.

Drugs Controller General (India) is the authority to grant permissions for the conduct of BA/BE studies with new drugs in India and Phase I studies. It normally takes about 6 weeks to get the permissions for the conduct of the BA/BE studies and for Phase I studies it may take longer.

Lotus Labs provides a range of services in clinical research that involves clinical study planning, designing, conduct of studies from Phase I to Phase III providing end to end services right from protocol writing, regulatory submissions to the statistical analysis and report writing.

Yes, Lotus Labs provides central lab services for clinical trials to Pharmaceuticals/ Biotech sponsors and to other Clinical Research Organizations too.

Central Lab (Medical Diagnostic Services) of Lotus Labs is accredited by NABL (National Accreditation Board for Testing & Calibration Laboratories) and CAP (College of American Pathologists).

Lotus Labs is approved by ANVISA and provides end to end services from protocol designing to final report generation. Lotus Labs will not be handling Pharmaceutical equivalence for ANVISA studies which need to be handled by the sponsor.

Lotus Labs has experience of completing more than 350 studies for USFDA and as per the information available more than 100 are approved by USFDA (June 2010). All Lotus Labs facilities have been inspected by FDA for specific studies.

Lotus Labs has experience with First in Human studies, Single Ascending Dose, Multiple Ascending dose study.

No. Lotus is in the process of tying up with channel partners for providing these services in the coming days

Lotus Labs has done many studies for EU submissions and the studies have been submitted to and approved by many EU countries. Lotus Labs has been audited by EMA, AFSSAPS & AGES for specific studies. Please contact us to know more.

Lotus Labs has experience with many vaccine studies. Studies on vaccines for Influenza on pediatric age groups (hospital based), healthy volunteer studies on Rota Virus and Malaria. We will also be initiating shortly studies on Rabies and Tuberculosis.

Lotus Labs has experience with Erythropoietin and GCSF.

Lotus Labs can provide Stand alone services for medical writing, Statistical Analysis, Clinical Conduct, Bioanalytical Conduct, Monitoring and Auditing.

Lotus Labs has been audited and inspected by authorities like FDA, EMEA, AFSSAPS, AGES, WHO, ANVISA, MCC (South Africa & Zimbabwe) and MOH Turkey.
Lotus Labs has successfully completed more than 39 such audits and is even approved for submission of studies in Israel and Sudan. More than 100 studies have been approved only by USFDA as per the information available. Lotus Labs studies have been submitted to more than 45 countries.

Lotus Labs has conducted studies for WHO submissions in the areas of ARVs(anti retrovirals) and Tuberculosis. Many of these studies have been approved by WHO and are featured in the WHO website.