Om SAI

The services covers study design, protocol & Informed consent form(ICF) development, CRF design, Ethics committee review, Selection of subjects, bioassay of drug / metabolite, Pharmacokinetic and statistical data evaluations, reporting of study results, and archiving of all study related data.

OSCR has 24 bedded clinical units in the same premises. OSCR has adequate recreation facilities to conduct bio studies in healthy human volunteers, including women and post-menopausal women.

The BA & BE studies are carried out as per the appropriate SOPs.

We conduct

• Fasting Studies
• Food Effect Studies
• Interaction Studies
• Multiple Dose And Steady State Studies
• Dose Linearity Studies
• Invitro-Invivo Correlation
• Pk-Pd Modeling
• Dermatopharmacokinetics

Phase II-IV Studies at OSCR

Our GCP trained personnel are competent to carry out the above functions which meet International standards. All project management activities are carried out in compliance with ICH and GCP guidelines.

We conduct

• First-Into Man Studies
• Feasibility Study
• Protocol Development
• Site Identification
• Clinical Investigator Selection
• Clinical Study Monitoring
• Clinical Trial Co-Ordination
• Clinical Trial Project Management
• Independent Ethics Committee Submission
• Regulatory Submissions
• Post Marketing Surveillance

Documentation, Statistics, Reporting, Archival

OSCR has separate data-processing sections for clinical documentation, writing protocols and making reports

OSCR has an in-house biostatistician using the latest versions of software (SAS, WinNonlin, etc) which is internationally accepted and enables preparation of flawless, accurate reports.

Archival facility: Complete data management / archival as per sponsors’ / regulatory requirements.

• CRF Annotation and Data Handling Manual
• Data Management Plan
• Customized Database Design & Development
• Data Entry With High Accuracy by Independent Double Data Entry
• Query Management through Computer-generated Tracked Data Clarification Forms(DCF)
• Full electronic Audit Trail
• Comprehensive Data Validation and Data Validation Reports
• Electronic Transfer (SAS Export Files)

Phase I - IIa & Bioavailability and Bioequivalence Studies

We have an onsite analytical laboratory, which is equipped with HPLC, LC MS/MS, and other sophisticated analytical instruments. We have more than 20 validated bioanalytical methods. Method development is a continuous process at OSCR. Our experienced bio analysis team can rapidly assay the samples for pharmacokinetic evaluation of compounds and their metabolites.

List of Available Methods

Sr. No	ANALYTE	LINEARITY RANGE	BIOLOGICAL MATRIX
1	Praziquantel	1000.000-2.000 ng/ml	Human Plasma
2	Metformin	4000.000-20.000 ng/ml	Human Plasma
3	Lovastatin	100.000-0.500 ng/ml	Human Plasma
4	S-Metprolol	150.000-1.000 ng/ml	Human Plasma
5	Losartan and Losartan Corboxylic Acid	800.000-20.000 ng/ml	Human Plasma
6	Atorvastatin and O-Hydroxy Atorvastatin	50.000-0.250 ng/ml	Human Plasma
7	Ciprofloxacin	8000.000-20.000 ng/ml	Human Plasma
8	Enalapril and Enalaprilat	500.000-1.000 ng/ml 500.000-5.000 ng/ml	Human Plasma
9	Ibuprofen	50000.000-100.000 ng/ml	Human Plasma
10	Goserelin acetate	50.000-3.000 ng/ml	Rat Plasma
11	leuprolide acetate	180.000-4.000 ng/ml	Rat Plasma
12	Sildenafil	1000.000-5.000 ng/ml	Human Plasma
13	Metronidazole	30000.000-200.000 ng/ml	Human Plasma
14	Octreotide	30.000-2.000 ng/ml	Rat Plasma
15	Trimebutine & desmethyl trimebutine	500.000-5.000 ng/ml 2500.000-25.000 ng/ml	Human Plasma
16	Loratadine & desloratadine	25.000-0.250 ng/ml	Human Plasma
17	Domepridone	150.000-1.000 ng/ml	Human Plasma

The quality assurance department at OSCR is dedicated in enhancing and ensuring the quality of all systems & procedures in an effective & efficient manner.

An independent QA department monitors and reviews the effectiveness of OSCR’s quality assurance policies & procedures.

The QA department comprise of a team of experts with a high degree of experience, integrity and work ethics.

Responsibilities :

• Preparation of Quality Manual and Quality Policy.
• Implementation of systems and procedures as per ICH - GCP and GLP guidelines.
• Preparation and implementation of SOPs.
• Training schedules of personnel
• Calibration schedule for equipments.
• Monitoring on-line quality control of systems and procedures
• Internal / External audits.
• Environmental protection
• Document Archival

• Clinical Trial Application from Drugs Controller General (India), Ministry of Health and Family Welfare, Government of India.
• Application to import clinical trial material from Drugs Controller General (India), Ministry of Health and Family Welfare, Government of India.
• Application to export clinical study related human biological samples for their analysis from Directorate General of Foreign Trade, Ministry of Commerce, Government of India.
• Application to License for export of clinical study related human biological samples for their analysis from Joint Directorate General of Foreign Trade, Ministry of Commerce, Government of India