We apply world-class knowledge and operational excellence to generate unique insights and deliverables on clinical development, in a cost-effective way.
This is how we leverage our clients´ potential to turn opportunities into healthcare value.
The traditional CRO model has become far from ideal: high costs, inefficiencies and lack of human touch on services delivery.
At Clinergy, we believe high-value comes from extreme focus and commitment to excellence.
We act as a cohesive, tactical and flexible elite team, as a true extension of our clients, and we only work on a selected number of projects each year (and plan to keep it that way), so that we deliver outstanding work on every single project we commit to take on.
Our unique mindset, processes and systems have been consistently recognized by pharma and biotech clients all over the globe as the cornerstone of high quality deliverables and innovative approaches to clinical development.
We pride ourselves on being the partner of choice of small to mid-size pharma and biotech companies from all over the world to deliver outstanding work across several therapeutic areas.
We strive to exceed expectations. Always.
"We have been impressed by the high degree of excellence and commitment."
" Seamless interactions. Feels like working as one team"
"Incredibly knowledgeable team."
"I wish we had found you guys earlier."
The challenge:
An Asian client needed to start a very large phase 3 trial in Brazil in record time.
What we did:
Clinergy´s team utilized management and delivery tools to leverage its capabilities in order to:
Results:
Clinical trial application performed within 38 days from contract signature with the sponsor.
The challenge:
Clinical stage French biotech struggling to meet recruitment target for phase 2 trial in infectious diseases ongoing in Europe.
What we did:
Brazil was included in the study in the “last mile”, with less than 3 months to perform all start-up activities and recruit patients. Clinergy selected 3 high performing sites and managed to get all start-up activities done within less than 2 months, from contract signature with the sponsor to Clinical Trial Application approval.
Our operations team developed a high-performing risk-based monitoring strategy in order to ensure data quality and speed.
Results:
Brazil´s initial recruitment target was achieved in 1 month. The sponsor then tripled Brazil´s target and we became the study´s top recruiter.
The challenge:
A large consumer health company needed to generate new claims for an established OTC product in Brazil, but had no budget for a clinical study.
What we did:
Clinergy performed a comprehensive literature and evidence review related to the target product and its competitors.
10 claims to support new messages about the products´ efficacy were created by Clinergy.
A critical assessment of the robustness of the evidence supporting each proposed claim was performed.
Results:
The client was so pleased with the outcome (which saved them millions of dollars), that they rolled out the new claims across several Latam countries.
The Challenge:
Japanese pharma company developing a new vaccine and looking into expanding its footprint into Latin America. The client needed, within a very short timeframe, key information around clinical trials planning and conduction in Brazil including aspects such as the type of clinical data to support marketing authorization, site selection, contracting and payments to sites, supplies importation, requirements for clinical trial applications, typical queries issues by authorities during CTA review, among others.
What we did:
Clinergy´s team promptly assessed all answers raised by the client not only from a technical point of view, but also from a strategic and risk mitigation perspective.
Results:
Clinegy´s team delivered, within 3 working days, a comprehensive report with detailed answers to all 23 questions raised by the client, providing technical and strategic information to allow the client to confidently assess its clinical development plan.
The Challenge:
European clinical stage biotech developing an innovative cell therapy product wanted to align key points of their clinical development plan with ANVISA for an upcoming phase II study in Brazil.
What we did:
Within only 10 days after receiving the clients’ clinical and CMC documents, Clinergy: built a tailored risk-based strategy for the SA meeting; took the client through the SA meeting request and conduction process in Brazil, expected outcomes, timelines and tips based on Clinergy’s extensive experience; Guided the client through possible contentious points for their specific case that could be anticipated and aligned with ANVISA before the clinical trial application to minimize regulatory risks; proposed questions to be validated with ANVISA and helped the client building the best narrative; prepared the briefing book and the slide deck submitted to ANVISA as pre-read material.
Results:
The meeting was a huge success, the client was very pleased with Clinergy’s actions before and during the meeting by ensuring all points would come across clearly, with help on technical and strategic translations when needed during the meeting.
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"Highly professional staff"
Global Clin Ops Director, Acticor Biotech (France)