Project Management for Bioequivalence Studies

What is OnTrack

Managing your Bioequivalence Study from Product Feasibility to Report Submission.

From the preparation of product feasibility, CRO selection, managing execution of pilot and pivotal bioequivalence studies, interpreting pharmacokinetic & statistical bioequivalence results to clinical study report submission is a long and complex process. These activities can be smoothly completed if there is an expert team available with different skillsets. Also, this is complex journey where coordination from different individual departments or skillsets are needed with precise planning for solution in advance. It is very unlikely that any generic company can have all required skillset and expertise in-house, which may lead to excess time due to lack of expert advice. Hence, it is advisable that company should focus on their core areas and leave these challenges to us to manage".

Solution

ONTRACK as the name suggests, is all about PROJECT MANAGEMENT, a comprehensive project management solution, where we undertake responsibility for site selection, project planning, coordination, execution of bioequivalence study, report review till the dossier is submitted to regulatory authority. As name suggests, ONTRACK means keeping project ONTRACK and deliver it on time. Our dedicated and experienced project managers will coordinate with all concerned team members for timely delivery and will ensure that product gets into market within the required timeframe. Having vision of journey with good start is half done. Our services ensure and offer solution where we coordinate and are stop gate for Sponsors, Formulators & CROs for start to end bioequivalence study. ONTRACK is being delivered by well experienced team and software module is controlled by dedicated technical team. Our well-defined checklists and appropriate checkpoints ensure smooth flow of a simple or complex project.

On Track Features

CRO Selection

Before assigning the project to CRO, our team perform system based audit. Our system and checklist verifies capabilities of a CRO based on which we consider if should qualify CRO or not? During project initiation and assigning project we perform following activities :

Regulatory Inspection History and Interpretation
Master Service Agreement
System Audit Report
Quality Management System

Feasibility Assessment Report
Standard Operating Procedures
Site Initiation Visit Report
Data Integrity Check

Process (Pre-study)

During pre-study process, our team verifies and ensure if pre study processes for the biostudy are carried out as per defined, which includes the following:

Study Monitoring Plan and Agenda for Monitoring visits
Approval for Analytical Method Validation Report
Shipment of IMP and Clearance
Resolution of IMP related queries and concerns

Signing off Project Agreement
BENOC and TL Approval
Sponsor Protocol Approval
IEC / IRB Approvals

Process (During Study)

Following procedures and activities are performed by project managers and team after completion of operational activities:

Monitoring of Dispensing Activities
Monitoring of Dosing Activities
Study Monitoring Observation and Findings
Resolution of Study Monitoring Observations and Findings

Dosing updates for each period
Confinement / Clinical Study Updates
Subject Sample Processing

Process (Post Study)

Following activities are completed by our project managers and QA team after completion of study activities:

Resolution of Study Monitoring Observations and findings
Study Monitoring Report
Pharmacokinetics and Statistical Report
Additional Documentation as per Regulatory Needs

Close Out Visit and Meeting
Clinical Study Report
Analytical Study Report
eCTD Submission

Project Management Tool

Our team does not rely on personal skills but also use Project Management software tool which has all essential checklists & provides alerts and directions to our project managers for respective tasks to ensure very limited human dependency.

Project Management Tool / Software
Task and Deliverable List
Comprehensive Checklist

Two stage Approval Process
365 days availability

Benefits

"ONTRACK" service offer following benefits:

Skilled and expert Project managers
Legal proof agreements
Cost saving approach
Complete review to avoid hassle-free submission
Check points to ensure error free process

Define checkpoints
Steps to squeeze Time line
No worries to sponsor
Complete tracking of projects
Expert opinion at critical step

Deliverable

"ONTRACK" service offer following benefits:

Sponsor – CRO Correspondence
Master Service Agreements and Project Contracts

Individual Study Reports
Dossiers

Timely Delivery

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Services

PRE STUDY

Product Feasibility
Site identification & Qualification
Regulatory approval/BE NOC & T License

CLINICAL PHASE

Product Feasibility
Sample Size estimation or Approval
Statistical Design or Approval
CRF, ICF, ECG, CSR Review
Study Monitoring & Study Compliance
Study Monitoring observations & reporting

BIOANALYTICAL PHASE

MD MV & Analytical data Review

STATISTICAL PHASE

Statistical & PK report review & Data Interpretation
Root cause analysis

TRACKING OF PROJECT

TRACKING OF PROJECT

REGULATORY

Scientific Advisory Meeting
Biowaiver & other Regulatory Query Response
Controlled Correspondence with Regulatory Authority

Qualified & well experience
team that work as your local expert

Perform end to end Project
Management of Biostudy - OnTrack

What is OnTrack

Managing your Bioequivalence Study from Product Feasibility to Report Submission.

Solution

On Track Features

CRO Selection

Process (Pre-study)

Process (During Study)

Process (Post Study)

Project Management Tool

Benefits

Deliverable

Timely Delivery

On Track

Provides solution to following challenges

Challenges 1

Compare Services

Qualified & well experience team that work as your local expert

Perform end to end Project Management of Biostudy - OnTrack

What is OnTrack

Managing your Bioequivalence Study from Product Feasibility to Report Submission.

Solution

On Track Features

CRO Selection

Process (Pre-study)

Process (During Study)

Process (Post Study)

Project Management Tool

Benefits

Deliverable

Timely Delivery

On Track

Provides solution to following challenges

Challenges 1

Compare Services

Qualified & well experience
team that work as your local expert

Perform end to end Project
Management of Biostudy - OnTrack