gsbioresearch

Services

A complete clinical development service from Phase I to IV. Our primary goal is to collect reliable, quality data while establishing the safety and efficacy of developing products. 

GenSafe Bio Research’s comprehensive Clinical Development platform assists right from early clinical phases till the end of the study. Our consistent focus has been to secure the quickest approval process follow through. Working together with our partners, we create a solution base for the right molecule(s) awaiting market access. We ensure global clinical trial needs are met through our highly integrated services. 

Quality system works towards achieving high quality, high-performing service that meets and the Client’s expectations 

GenSafe Bio Research’s  dedicated, independent quality assurance team, focus on quality that imbue the entire span of process  within the reach  of all services at GenSafe Bio Research . It’s reflected   in scrupulous implementation of various Quality Assurance (QA) procedures 

Quality assurance ensures the strict implementation of cGMP, GLP & GCP 

Qualified auditor verifies the on-line process, internal quality audits (safety, quality and data integrity) 

 Handle customer suggestion time to time for improvement of quality 

 Instituted routine training & qualifying tests to keep all personnel alongside with the latest developments and have also ensured uniformity and consistency by implementing process standardizations at all levels. 

A much-specialised function and we understand the needs of Bioanalytical stage requirements   

Bio equivalence(BA/BE)  study design, complete monitoring of study including raw data  to report review  GAP Analysis  between regulatory and also help to find which process need to be fixed    leading to product profiling. 

We provides a complete BA/BE Protocol translation solution for CROs that are engaged in clinical trials for approval of a new drug. This includes certified translation of clinical protocols into all EU languages, as well as most Asian languages. 

We at GenSafe Bio Research  providing auditing services such as GAP analysis in CRO &  pharmaceuticals, GAP assessment in the pharmaceutical industry, GAP analysis and facility assessment, etc. GAP analysis is a way to compare current conditions and practices in order to identify gaps and areas in need of improvement with regards to compliance with the relevant standards, defined by Regulatory  Authorities.  

We follow all the guidelines of all current practices and make a review for adequacy, suitability, effectiveness, compliance. Here at GenSafe Bio help to the CRO & Pharma industries to identify all the Gaps and also help to find which process need to be fixed like quality management process, internal communications process, document control process, record keeping process, training process, internal audit process, management review process, measuring and monitoring process, non-conformance management process, and continual improvement process. 

Medical Writing is an integral part of clinical research and GenSafe Bio Research’s  team of medical writers deliver accurate, timely, and cost-effective clinical and regulatory documents to the highest quality and scientific standards. 

Our medical writers become an extension of your team by being responsive and flexible to your needs, using our expertise to transform your complex and diverse data into an accurate and evidence-based account of the clinical profile of your drug in relation to treatment and patient safety. 

We have a wide breadth of knowledge and experience drawn from the pharmaceutical industry, clinical research organizations, and academia. All documents produced by GenSafe Bio Research  undergo thorough scientific, statistical, editorial and quality control review. 

The Medical Writing services offered by us include: 

Bioanalytical reporting 

Method Validation Reports 

Bio analytical Reports 

ISR Reports 

Submission-ready Documentation    (Hyperlinked eCTD formatting)    Dispatch  

Clinical Reporting 

 Clinical Study Reports 

 Integrated Safety & Efficacy Reports 

Pharmacovigilance & Safety Reports 

Presentations, Posters & Manuscripts 

Computer system validation /GxP 

Our computer system validation experts  validate  computer for all types of USFDA-regulated businesses, including pharmaceutical and biologics manufacturers, medical device manufacturers, clinical research organizations, and GLP laboratories  described in the FDA 21 CFR 11.10(a) and EMA Annex 11, Section 4 

On Target Risk Assessments  : 

Once we have an understanding of risk probability, severity, and detectability, we can effectively mitigate risks in the CSV process. We identify specific  functions and features that should be tested and optimize the testing level for each. GS BIOs risk assessments feed into validation plans that are compliant and efficient. 

System Specific Validation Plans 

We create validation plans that are custom to each client: experience has taught us that generic plans are not one size fits all. GS BIOs experts work closely with client teams to understand business and data processes to create a validation plan that incorporates CSV best practices and clients’ specific needs. 

Thorough Test Scripts 

Test scripts are the centre of the CSV process and must completely exercise your requirements and system specifications to prove intended use. GS BIOs experts have decades of experience writing test scripts unique to how each customer uses laboratory informatics in their environments. Our scripts leverage our knowledge of clients’ business and laboratory needs to minimize risks, cost, and time required. 

Detailed Documentation and Reports 

Clear and concise CSV lifecycle documentation following a GAMP®5 risk-based approach makes your systems defensible during an audit. GS BIO s documentation stands up to auditors’ scrutiny so you can feel confident in your laboratory computer systems and  therefore your laboratory data. 

GS BIO s validation experts support a full range of validation activities: 

 

    Validation planning 

        Develop system-specific validation plans 

        Conduct an inventory of hardware and software systems 

        Develop user requirements specifications (URS) 

     Develop functional requirements specifications (FRS) 

        Develop system configuration specifications 

        Develop system design specifications 

        Perform functional and quality risk assessments 

        Perform vendor audits  

  Testing 

        Execute hardware installation qualifications 

        Execute software installation qualifications 

        Develop software installation, operation, and performance qualifications (IQ OQ PQ) 

       Execute IQ OQ PQ scripts 

        Develop a traceability matrix 

        Implement system configuration  

    Go-live preparation and reporting 

        Develop validation and testing summary report 

        Create system release documentation 

        Create and/or update standard operating procedures 

        Create data migration and verification plans 

        Execute data migrations and verifications 

        Decommission legacy systems  

 

We provide peace-of-mind during project planning and execution by assigning the right resource to fit your needs. GS Bios experts include experienced CSV project managers, team leaders, and subject matter experts to support your project from beginning to end and allow laboratory staff to stay focused on their daily activities.