STRENGTHEN YOUR CLINICAL DEVELOPMENT STRATEGY

Since the development of a drug or a medical device is a long-distance race to find funding and because budget tracking and management of timelines will allow you to keep control of your project.
Athena Bio Consulting is at your side to help you face this challenge, to identify your assets, your needs and guiding you along your way.

SCIENTIFIC EXPERTISE

To enable you to meet your objectives by assuring your scientific and medical evidence strategy..

METHODOLOGICAL EXPERTISE

To protect your development timelines and budget with innovative analytical tools and study designs.

SCIENTIFIC, MEDICAL, REGULATORY AND FINANCIAL RISK EXPERTISE

To reassure and convince your investors and partners in terms of timescales, costs and risks.

AT EVERY STEP OF YOUR PROJECT

Because each new piece of scientific data, be it internal or external, must be taken into account, your clinical development plan must be continuously updatable to reach your objectives.
As a partner, Athena Bio Consulting will assist you either for each phase or throughout, depending on your requirements; from preparing your first-in-human study to the granting of Marketing Authorisation or obtaining CE marking.

ESTABLISH A RIGOROUS AND TARGETED PHASE I PLAN

Enter the clinical trial phase safely and prepare the move on to proof-of-concept studies as quickly as possible.

ESTABLISH A DARING AND ADAPTIVE PLAN FOR PHASE II

To set up your proof of efficacy trials and rigorously define the administration conditions for your future medicine.

ESTABLISH A BOLD PHASE III PLAN IN LINE WITH CURRENT MEDICAL KNOWLEDGE

To prove to the health authorities and KOLs the value of your medicine for your future patients

ESTABLISH A SIMPLE, EFFECTIVE CLINICAL VALIDATION PLAN WHICH MEETS REGULATORY REQUIREMENTS

To prove the efficacy and safety of your therapeutic or diagnostic Medical Device.

Throughout all of these steps, Athena Bio Consulting will take care of drafting of protocols, analysis plans, Investigator Brochures, study reports, evaluation reports and scientific articles.

Athena Bio Consulting will also support you in choosing your CRO partners and the operational follow-up of your study.

YOUR PRODUCT IS UNIQUE AND INNOVATIVE, ITS DEVELOPMENT WILL BE TOO

Since a young and innovative company is not on the same scale as a big pharma, you need to find attentive partners that will make the most of your agility and daring.

Without formatted models, we will immerse ourselves in your scientific project and your business plan, so that together we define the most suitable plan for your future medicine or device.

Depending on your situation, you will need the right expertise as well as specialized CROs to best meet your needs.

WHEN YOU PARTNER WITH ATHENA BIO CONSULTING, YOU ENSURE THE SUPPORT OF A LONG-TERM BUILT NETWORK OF EXPERTS

Since all BioTech and MedTech companies are different, when it comes to time and risk, you need a tailor-made proposal.

ATHENA BIO CONSULTING WILL CREATE ONE OR MORE PROPOSALS FOR YOU WITH A RISK ANALYSIS TO INFORM YOUR DECISION MAKING.