Biointegrity Consulting

Biointegrity Consulting

Be Compliant… Be Safe…

Biointegrity Consulting of 6

Trifecta Sollievo, Whitefield, Bangalore, India

www.biointegrity.in

[email protected] Phone Nos.: 0(91)9886081175

Biointegrity Consulting Services

1. Bioequivalence/Clinical study management

We have decades of experience in Bioequivalence/clinical study management. We have two type of mode of operation, as described below:

1. We can choose the CRO for you, as per your requirement and manage the study.

In this we will choose CRO, negotiate the quotation, will manage the signing of contract and other legal requirements, will manage the timeline, we will do audit of CRO as per regulatory requirement and will review all technical documents after the study.

2. You will choose the CRO, we will manage your study, in coordination with your preferred CRO.

In this we will manage the timeline, we will do audit of CRO as per regulatory requirement and will review all technical documents after the study.

2. Protocol review

Protocol designing is the most important part of bioequivalence study/clinical study. So it is recommended to check the protocol, suggested by the CRO/BE centre. Our experienced team can review your protocols and suggest number of volunteer required, study design, time points, precautions required for unstable and highly variable molecules etc. We have very good experience in dealing highly variable molecules (ex: Atorvastatin, Colistin, Clopidrigrel) and unstable molecules (Ex: Cefaclor, Vitamin-A).

3. CRO pre-qualification audit (Feasibility Audit):

This will help the company to choose CRO for the bioequivalence study/clinical study.

We will check SOPs, documentation system, staff training record and experiences, instrumentation records, previous regulatory body’s audit report, regulatory affiliations, GLP/GCP/GDP compliance, method validation/method development data of molecule of your interest, suitability of Bioanalytical method for your molecule. We also ensure that the overall system and practices are in line to the major regulatory guidelines and as per acceptable industry standards.

4. Clinical Phase monitoring

In Clinical phase monitoring service we ensure that, the study is conducted as per compliance with regulatory guidelines (GCP), protocols, SOPs, contracts, agreements and other written procedures. We also assess the adherence of Good clinical practices at clinical study site. Our Clinical phase monitors have 10+ year experience in BA/BE clinical phase CROs. We cover all critical check points with a pre defined check list during monitoring. We ensure the data integrity and ethical standards followed at all the stages of the study conduct to assure the sponsor.

Clinical phase review includes (but not limited to):

Regulatory and ethical committee approvals

Trial master file and investigational product compliance





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Protocols and agreement compliance

Registration and selection criteria

Subject enrolment and dosing

Sample collection and transfer

Storage conditions and tracking details

Case reports and consent forms

Safety and wellbeing of subjects

GDP and GCP compliance

5. Bioanalytical phase monitoring

Minimum one time monitoring is required, but depends on number of volunteers in study, monitoring may be done more than one time. Bioanalytical activity is the most critical activity in bioequivalence study. In this phase/activity the procedures affect the result of the study and also study approval by the regulatory agency. We offer Bioanalytical phase monitoring (in process monitoring) services to assess laboratory practices as per GLP regulations, adherence to the predefined internal standard operating procedures (SOP) and other regulatory standards. Our professionals are well experienced Quality Assurance auditors with Bioanalytical and Quality Assurance work experience.

Bioanalytical monitoring includes (but not limited to):

Sample processing audit (from solution preparation to transfer of samples to autosampler)

Online documentation procedure

Raw data forms

Instrument and other log book entries related to the study

All related instrument calibration status

Sample storage and retrieval procedure

Training records of the scientist.

All compliance as per SOP and protocol.

6. Bioanalytical data integrity review

We will do this after completion of study. This will check complete/detail quality of experimental data. Data integrity review includes (not limited to):

Review of raw data forms

Review of result table, chromatograms, calibration curve and all audit trails.

Review of SOP/protocol deviations.

CAPA documents and investigations.

Review of Report.

Correctness of concentration data.





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21 CFR part 11(electronic data handling) requirements

All instrument generated audit trails.

7. Report review

Submitting error free and well written report is one of the critical parts of Bioequivalence study/clinical study. Good report creates an impression of good data quality and understanding of technical matter. We can review your all reports (Method validation report, Bioanalytical report and clinical study report) before submitting to regulatory agency.

8. Regulatory response report review

Responding to regulatory queries is a very critical activity. After you got any queries from regulatory agency, approval of molecule depends on the justifications you provide to agency for query. So it is important to review the response report (prepared by CRO) by sponsor’s team or by external consultants. We have decades of experience in handling regulatory queries for all most all regulatory agency. So we can help you in responding regulatory queries.

9. Complete bioequivalence data/clinical data integrity review

We will do this after completion of complete study. In this service we will review all technical/experimental data. This is required to check compliance/quality of complete data. This service includes review of all:

Clinical data

Bioanalytical data

All Reports (Method validation, Bioanalytical, study report)

10. Bioequivalence compliance management

This is a cost effective and efficient quality management service in comparison to individual services. We will manage the total compliance of the bioequivalence study. This will include:

CRO pre-qualification audit (Feasibility Audit):

Protocol review

Clinical monitoring

Bioanalytical monitoring

Clinical and Bioanalytical data review

Report review

Regulatory response report review.





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11. Failed bioequivalence study route cause analysis.

We have expertise in route cause analysis of failed BE study. We will review the dissolution data, clinical data, Bioanalytical data, audit trails, PK and statistics calculations and other related documents and suggest you the reason of failure. Also we will suggest the future approach to succeed in BE study.

12. Annual contract service

In annual contact service we will give all type of bioequivalence service as per your requirement for all your molecules. Advantages of annual contact are as follows:

Cost effective in comparison to taking different individual service for different molecules.

Less documentation, as only one time contract and onetime non disclosure agreement need to be signed per year.

No limits on number of service and number of molecules except training services.

Two day training in your facility and two online training included in annual contract.

We will meet you in your facility minimum twice a year during one year contract.

13. CRO/BE centre establishment

We can provide end to end support to establish new CRO/BE centre. This will include:

CRO/BE centre clinical lab layout design.

Bioanalytical lab layout design

GAP analysis of the new facility.

SOP writing

Implementation of quality management work flow.

Instrument and other material purchasing support.

Recruitment

Practical training to the employees.

All other services required to establish the BE centre.

14. Training

We can give all theoretical and practical training related to bioequivalence study. Some of our training topics are as follows:

Over all conduct of Bioequivalence study.

Practical approach to achieve data compliance in Bioequivalence study.

Practical approach for clinical phase audit.

Practical approach for Bioanalytical phase audit.





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CRO screening

Data integrity review of bioequivalence data.

Bioanalytical Method development

Bioanalytical method validation

Pharmacokinetics aspects of Bioequivalence study

Biostatistics in Bioequivalence study

Bioequivalence Protocol designing

Bioanalytical and clinical study report writing.

Result table audit trail, project audit trail and Instrument audit trail review.

Clinical operation in bioequivalence study.

Hands on training on Bioanalytical sample preparation.

Bioanalytical documentation.(Good documentation practice)

Hands on training on stock weighing, pipette calibration, PH Meter calibration etc.

Introduction to Drug development and clinical research process

ICH-GCP overview

Ethics in clinical research

Ethics committee functioning, membership, registration, records management

Informed consent contents and workshop on key contents of ICF and AV recording

Investigators Responsibility and Safety reporting (AE, SAE reporting)

Clinical Operations challenges and day to day responsibilities of CRAs

GCP Data Integrity, Quality Assurance and Regulatory Audit compliance

Case studies about Regulatory observations, Inspection reports, Responses

Medical monitoring - responsibilities of medical monitor

Clinical trial protocol design discussion - BA/BE studies

Investigational products management and records management

15. Quality management system (QMS) design and implementation

We can design and/or implement QMS systems which are 21CFR part11 compliant. These QMS software’s will improve your documentation process and help you to deal more data with 100% compliance. These systems will manage your compliance without using any paper. By using these QMS software managing compliance will be systematic and easier. Kindly find some details below (not limited to):

a) Electronic lab note book (eLNB)

By using this QMS you can record all your lab activity online through a 21CFR part11 compliant system. An electronic lab notebook (ELN) is a computer program designed to replace paper laboratory notebooks. Lab notebooks in general are used by scientists and technicians to

https://en.wikipedia.org/wiki/Computer_program

https://en.wikipedia.org/wiki/Lab_notebook

https://en.wikipedia.org/wiki/Scientist

https://en.wikipedia.org/wiki/Technician





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document research, experiments, and procedures performed in a laboratory. Electronic lab notebooks are a fairly new technology and offer many benefits to the user as well as organizations. For example: electronic lab notebooks are easier to search upon, simplify data copying and backups, and support collaboration amongst many users. ELNs can have fine-grained access controls, and can be more secure than their paper counterparts. They also allow the direct incorporation of data from instruments, replacing the practice of printing out data to be stapled into a paper notebook.

b) Electronic Case report form (e CRF)

Auditable electronic record designed to capture information required by the clinical trial protocol to be reported to the sponsor on each trial subject is called an eCRF. The use of e-CRF can be a means to aid and accelerate the implementation of programs for pharmaceutical and clinical development and significantly reduce the logistics and study costs.

The advantages of e-CRF vs. Paper CRF:

Lighter logistics

Better data input quality

Privacy and security (password login, encrypted data, secure protocol)

Automated data entry control (automatic queries)

Centralised real-time quality control (indicators, display panels)

Secure automated randomisation with real-time alignment

https://en.wikipedia.org/wiki/Research

https://en.wikipedia.org/wiki/Experiment

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