Innovation Pharmaceuticals Inc (IPIX)

[LilyGDog]

That is main function of CRO assist in formulating trial proposals and supervising the trials and assembling the data.

AND THIS IS NOT SUPERVISION of CLINICAL TRIAL????

" What Are Clinical Research Organizations?

A CRO is an outsourcing company that a sponsoring company hires as an independent contractor to lead clinical trials and other research support services on its behalf. CROs typically contract with companies in the pharmaceutical, biotechnology, or medical device industries, but their clients also include governmental institutions, foundations, and universities. These organizations contract with CROs to acquire the specific expertise needed to carry out trials safely and efficiently without hiring permanent staff.

Given the complexity of drug and device development and the need to bring products to market rapidly to edge out the competition and meet patient needs, pharmaceutical companies are increasingly outsourcing critical functions including manufacturing and research. This has led to a surge in the hiring of CROs.1?

CROs play a key role in all aspects of the drug or device development process, from initial discovery to launch, but focus on Phase I–III clinical trials.2? Trials require a host of complex activities ranging from protocol design to preparation of materials for submission to the Food and Drug Administration (FDA).3? Rather than hire permanent employees with the specialized knowledge needed to perform these tasks in-house, trial sponsors such as pharmaceutical companies can outsource them to a CRO by formally transferring their responsibilities to the CRO in writing.

The CRO, acting as an independent contractor with specialized knowledge, can perform a range of tasks on behalf of the sponsor to help bring new drugs or devices to the market faster, more efficiently, and at a lower cost."


example: https://scope-international.online/services/


STRATEGIC CONSULTING

Development plan
Product development
Scientific advice
Pharmacoeconomics
Regulatory guidance

–STUDY EXECUTION

Clinical trial planning
Collaboration with phase 1 units
Proof of concept / feasibility studies
Protocol design
Paediatric investigational plans

-Contact us to discover how we can support your clinical operations:

Feasibility and planning
Project Management
Clinical Monitoring & Site Management



Clinical trial protocols and protocol amendments

Subject information and informed consent forms (ICFs)

Integrated clinical trial report meeting global regulatory requirements

Observation plans and final reports for post-marketing studies

Development safety update reports (DSURs)

Paediatric investigation plans (PIPs)


OUR CDM SERVICES

CRF design

Electronic Data Capture setup

Data Management plan

Clinical database setup

Data Validation Plan

Data review, reconciliation and cleaning

Data transfer specifications and data integration

Team trainings

Double-data entry

Data quality control

Status reporting

Ad-hoc reports

Centralized evaluations, e.g. central-diary evaluation and clinical outcomes assessment evaluation

Randomization and custom IMP logistic workflows

Database lock

Scanning and bookmarking

Archiving deliverables

Biostatistical Services

SAS® Programming

Data mining and exploratory data analysis


Safety Management

Experienced and expert drug safety physicians

Medical monitoring combined with data management for highest safety standards

Full range of medical services – monitoring, writing, coding, pharmacovigilance and 24/7 consulting

Medical expertise to support your study and goals


Quality Management

Clinical Trial Protocol

Informed Consent Form (ICF)

Investigator sites

Clinical Database

Clinical Trial Report (CTR)

Local and Global Regulatory Affairs



Advice on regulatory procedures for clinical studies at any stage in the process.

Preparation and submission of initial applications and substantial modifications under involvement of our local study teams

Local accompanying of the approval process and communication with competent authorities as well as ECs / IRBs and other parties

Reporting, notification for information during and after the clinical study (non-safety and safety via Pharmacovigilance)

Reporting, notification for information during and after the clinical study

Import / export licenses (incl. narcotics and psychotropic drugs)

Support in entering information in registry platforms and databases (incl. result disclosure)


Trial Master File (TMF)

Third-party service providers

Case Report Form (CRF)


Vendor Management