KS Bio Clinserve

Clinical Research & Site Management Services:

Our team works closely with sponsors/partners to deliver the highest quality of clinical trial data. Our teams are flexible and ensure to maintain quality standards to meet the sponsor requirements for completion of assigned projects within the stipulated timelines.

We ensure the conduct of clinical study in compliance with regulatory and ICH-GCP guidelines with strict adherence to the protocol and sponsors requirement. Our clinical research services include but not limited to Site Identification, Feasibility Assessment, Pre-study Visit, Selection of ICH-GCP Trained and Qualified Investigators, Ethics Committee Submission of Study Documents and Obtaining Approvals, Site Initiation Visits, Site Monitoring, Medical Monitoring, Data Management, Site Close Out and Data Archival.

Regulatory Services:

Our teams are well equipped, trained and proficient in providing regulatory support for our clients in the following areas:

Preparation, review and submission of Clinical Trial Application (CTA) and dossier.
Protocol presentation (prior to start of study) & Clinical Study report (after completion of study) to Regulatory Authorities/Expert committee for obtaining approvals of the same.
Preparation and submission of study status to ECs at site-level and also to the National Regulatory Authorities as per the guidelines.

Medical/Pharmacovigilance & Allied Services:

The following type of documents are prepared by our medical writing team:

Preparation of Non-clinical study reports
Clinical trial protocol synopsis
Full protocols
Quality of Life questionnaire
Informed consent forms
Subject Information Sheet
Subject/patient diaries
Patient safety documents
Investigator Brochure
Interim CSR
Final CSR
Review of trip/monitoring reports
Medical monitoring reports
Handling and resolution of AEs and SAEs
Preparation of SAE Narratives and submission to ECs and Regulatory Authorities within stipulated timelines
Annual Safety Reports

Data Management:

CRF Designing, Review & Printing (Paper CRF)
Electronic data capture (EDC) using electronic case report forms (eCRFs) implementation
Preparation of Data management plan (DMP)
Designing of Database, set-up and Validation
External data entry into CRFs (eg., Central Lab data & any other sponsor specific data etc)
Independent Double Data Entry & reconciliation
Randomization system
Data validation includes edit checks and query generation
Medical coding using MedDRA ® / WHO DD ® or any sponsor specific valid dictionaries
Quality Control
Data Review
Database lock

Biostatistical Support:

Our team of biostatisticians and statistical programmers are experienced in creating and developing the following:

The important aspect for study design include sample size estimation or statistical power analyses
Statistical Analysis Plan (SAP)
Randomization
Preparation of Statistical TLGs
Perform statistical analyses using Statistical Analysis System (SAS ® )

Clinical Quality Assurance:

Our team works closely with in-house monitors and train them in project specific areas to comply with the ICH-GCP guidelines and local regulatory requirements.

Training of in-house as well as the clinical trial site personnel on regulatory audit/inspections
Review of ongoing CT documents for compliance
Auditing of investigator sites, vendors, databases and trial related documents
Preparation and updating of SOPs
Regulatory support

Our Services