PharmaFacts’ cardiac risk-benefit assessment expertise is highly regarded in the industry. We help you put together the right studies that address cardiovascular safety issues.

If your drug candidate came up short in preliminary safety assessments, or even in clinical trials, your next step is risk assessment. In this make-it-or-break-it moment, you want to ensure your risk assessments are accurate and comply with regulatory guidelines.

When positive signals are detected, preclinically or at the clinical stage, understanding the findings within the appropriate context of risk-benefit is PharmaFacts’ specialty. Investigation of the underlying mechanisms and even identifying sub-populations for whom the drug is still acceptable may be necessary.

In addition to cardiac risk-benefit assessment, PharmaFacts also provides:

• CNS risk-benefit assessment
• Respiratory risk-benefit assessment
• Supplemental studies
• Program/study GAP analyses
• White paper writing

PharmaFacts provides highly trained scientists to take your preclinical drug development from discovery to IND success—and every step in between. We step in when you need us most.

If your pharmaceutical development progress has experienced setbacks, or if you find yourself in unfamiliar territory with regulations, or if you simply don’t have the expertise to make sure every ‘t’ is crossed and every ‘i’ is dotted in your preclinical study design, we can help.

PharmaFacts’ expert scientists are dedicated to your needs and will help you identify deficiencies and get back on track to IND success. We support every aspect of preclinical drug development with a focus on cost efficiency, quality, and timeline adherence.

PharmaFacts’ knowledgeable and responsive consultants can advise on any step of your drug development process from inception through preparation of submission-ready reports. Whether you are dealing with issues in one area or prefer complete oversight, we can solve difficult problems or manage and execute the entire complicated process.

• Investigative study design and oversight
• Discovery and lead candidate selection
• In vitro screening
• Chemistry (CMC, bioanalytical, formulation)
• Assay design and preclinical animal model selection
• Data analysis/interpretation and scientific writing
• Due diligence
• Proof of concept
• Cause/effect evaluations

PharmaFacts’ extensive experience and long-standing relationships with contract research organizations (CROs) allows us to help you select the CRO best suited for your needs.

Selecting a CRO for your preclinical studies is not a streamlined process. The number of CROs continues to increase, and separating the wheat from the chaff, so to speak, is not always easy. Once you do find a few quality CROs that seem to meet your needs, knowing who to contact to eliminate unnecessary steps is key.

PharmaFacts will save you time and money by efficiently identifying CROs that are best qualified to carry out your study effectively.

CRO selection is not a decision to make lightly. Our careful selection process will help you feel confident in your CRO choice.

• Best-fit CRO selection
• CRO audit and prequalification
• Ensure faithful and accurate representation of data
• Ensure adherence to regulatory guidance and timelines
• Ensure protocol compliance and data accuracy
• Study monitoring
• Statistics and data management
• Report writing

PharmaFacts understands how to implement quality management in stages over the course of the drug development process according to what is appropriate for your biotech company.

Regulatory expectations are that you have appropriate quality management systems in place. In partnering discussions, this will also be under scrutiny. To treat quality management as simply a checkbox exercise can result in big problems down the road. Instead, careful tailoring and staging of quality management systems will give you the coverage you need.

PharmaFacts will help you determine the right moment, and appropriate manner, to use your resources for quality management in all three areas of oversight – GMP, GLP and GCP.

We can help you decide whether a technical audit is sufficient, or a full QA audit is appropriate, and will provide qualified experts to guide the process. We can point out the stage when policy documents need to be expanded into SOPs, and help you write them.

• Quality management
• Quality systems assessment/GAP analysis
• SOP writing
• Quality reports and audits
• Preemptive contingency plan oversight

PharmaFacts understands regulatory expectations and can help you stage your preclinical studies in parallel with your clinical program to prepare you to make impactful decisions.

From pre-IND meetings and guideline interpretation to final NDA submission, or even resubmission, we can help you develop a strategy that prepares you to interact with regulatory bodies. Establishing a relationship with the FDA early is worthwhile so that you can best understand their expectation and avoid unnecessary work and expense.

PharmaFacts can help you understand reasonable, usual, and customary practices so that you feel comfortable making the decisions you face. We operate both in and out of the United States and are also able to cover regulatory needs globally.

• Regulatory strategy
• Expert FDA representation
• EMEA negotiation and support
• Advisory committee participation
• Preparation of preclinical regulatory dossiers (e.g., IB, IND, NDA, 505(b)(2), European Cosmetics Regulation, ISO 10993 compliance)