Our Services

What is a Preclinical CRO Consulting Agency?

We are a specialized consulting firm that guides biotech, pharma, and academic clients through the nonclinical/preclinical phase of drug development. We help you design optimal studies, select the best Contract Research Organizations (CROs), manage execution, ensure regulatory compliance, and interpret results to accelerate your candidate's path to the clinic (IND/CTA). We handle

At what stage of development should we engage your services?

The earlier, the better. We can add significant value right from Lead Optimization and Candidate Selection by designing your enabling nonclinical program. However, we also frequently assist clients who are already engaged with a CRO but need strategic input, troubleshooting, risk management or project management expertise.

What types of disease areas/fields do you specialize in?

Our expertise spans a wide range, including neurological disorders such as Alzheimer’s Disease and Parkinson’s Disease, autoimmune diseases such as Systemic Lupus Erythematosus, Immunology, Oncology, Immunotoxicity, Pharmacokinetics, In vivo models, Cell therapies and much more.

Do you perform the studies yourselves?

No, we are purely a consulting, project and strategic management agency. We do not operate labs or perform bench work. We partner with and manage third-party Contract Research Organizations (CROs) that perform the actual preclinical studies.

CRO Selection and Management

How do you help us select the right CRO?

We conduct a rigorous, unbiased selection process based on your specific study needs, budget, and timeline. Our consultants with highly specialized experience in their respective fields are able to communicate and assess on a deeply technical level, which CROs are the best suited for the job. The CROs we select are also those with proven track records that meet our own internal quality assessment criteria and international quality standards.

What is your process for managing an ongoing study?

Our management includes establishing clear project milestones, regularly scheduled project updates, detailed protocol and report review, budget tracking, quality assurance oversight, and proactive risk mitigation to keep your study on time and budget.

What if a study runs into technical issues or delays?

As scientists first and foremost, we understand that experiments and projects rarely progress without any hiccups. It is for this same reason that we proactively anticipate and mitigate potential issues up front. When an unforeseen issue appears, we immediately investigate and document the root cause, propose technical solutions (e.g., protocol amendments, method refinement), and manage communications with you and the CRO to implement corrective actions quickly and minimize impact on the overall timeline.

Data Integrity, Confidentiality and IP

How do you ensure the confidentiality and security of our proprietary data and Intellectual Property (IP)?

We are committed to ensuring all communications, data, details related to the study and project are kept strictly confidential. Upon project initiation, we will require a non-disclosure agreement (NDA) to be signed between Vivogenia and your Company for the purposes of carrying out this project. We also sign an NDA with the respective partner labs to ensure that they are obliged to keep your data protected. As an additional layer of protection, we blind the partner labs to the identity of the test articles, cell lines, mutations, and any other relevant details unless necessary for the project. Naturally, we will also discuss the disclosure of any information to the CRO with your Company before proceeding.

Who owns the data generated during studies you manage?

The client (you) always retains full and exclusive ownership of all generated study data, reports, and associated intellectual property. We act purely as your consultant and representative.

Do you follow specific data integrity standards?

Yes, we emphasize ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, and Complete/Consistent/Enduring/Available) in all data review and handling processes, especially when working with GLP-compliant CROs.