Clinical & Medical Affairs Capabilities

Kymanox provides industry leading scientific and medical expertise to ensure efficient and compliant clinical activities and best in class medical affairs solutions to support the development of drugs, devices, and combination products with support from our world leading subject matter experts.
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Extensive Expertise 

Support for cGCP compliance, CRO and investigator site audits, pharmacovigilance, clinical trial protocols, preparation of clinical and performance evaluation reports, development of risk-benefit analyses, and compliant investigations.
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Navigating the Clinical and Medical Affairs Landscape

We are experienced in efficient navigation through the multidimensional clinical and medical landscapes and interpretation of applicable FDA and EMA regulations to ensure compliance.
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First-in-Class Product Support

We emphasize a patient-centric, risk-based approach that supports the introduction and ongoing support for a variety of products, their unique challenges including first-in-class drugs and devices.
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Kymanox Clinical & Medical Affairs Solutions Resources

Infographic

Infographics The Pre-Approval Inspection (PAI) is an important step in getting your product to market on time and on budget. Avoid costly delays by getting inside the mind of your PAI inspector and go into the process fully prepared: 

Webinar

Webinar “A Patient-Centric Approach” The European Union is making a major upgrade to its Medical Device Regulations (MDR). Device developers and manufacturers will face greater responsibilities for electronic reporting, device labeling, and data sharing. Learn what you need to do now to prepare.

Meet our Clinical & Medical Affairs Solutions Experts 

Dr. Izi Bruker, PhD, MPH
SENIOR VP, CLINICAL, MEDICAL, AND REGULATORY AFFAIRS
RachelLeahy

Markets That Benefit from Our Clinical & Medical Affair Solutions

Combination Products

Our experts understand the interaction between devices and drug products. Our experience includes injectables, nasal, respiratory, and more.

Biologics

We understand why “the product is the process” and how to implement solutions to your unique challenges.

Pharmaceuticals

Drug development is constantly evolving with new regulations and technology. We stay up to date to maintain your compliance.

Other

Our diverse experience across the life science industry, including medical device and vaccines, ensures your challenges are in expert hands.

The Kymanox Clinical & Medical Affair Solutions Difference

Our clients tell us traditional integrators simply do not fully understand the complexities of working in a highly regulated environment. The Kymanox team lives in regulatory environments every day so you’ll get practical solutions.
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Right First Time Execution

Our branded methodology, Ideal Knowledge TransferTM, combines technical project management, fundamental engineering practices, quality and regulatory expertise, and business acumen.
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Multidisciplinary Approach 

Kymanox ensures requirements are met for biotech, pharma, medical device and combination product clinical trials by engaging our board-certified Medical Doctors, Ph-D and MPH level Subject Matter Experts (SMEs) in Quality, Regulatory, Safety, Biostatistics, and Biomedical Engineering.
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Flexibility & Agility

At Kymanox, we make it easy for clients to get the solutions they need, when they need it. Clients tell us our flexibility is one of the key reasons they keep coming back.
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Frequently Asked Clinical & Medical Affair Questions

What is Electronic Trial Master File (eTMF) completeness?
The Electronic Trial Master File (eTMF) must contain all information to reconstruct and tell an accurate story of the events that comprise the clinical study. Your eTMF will be considered complete when all the documentation collected throughout a clinical trial is available in the eTMF in an organized and auditable way. 
How long should clinical trial records be kept?
A sponsor shall retain the records and reports required for 2 years after a marketing application is approved for the drug; or, if an application is not approved for the drug, until 2 years after shipment and delivery of the drug for investigational use is discontinued and FDA has been so notified.  An investigator shall retain records required to be maintained for a period of 2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication, until 2 years after the investigation is discontinued and FDA is notified.
What is Bioresearch Monitoring (BIMO)?
Bioresearch Monitoring (BIMO) is the FDA’s comprehensive program of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA regulated researchThe BIMO program was established to assure the quality and integrity of data submitted to the agency in support of new product approvals and marketing applications, as well as, to provide for protection of the rights and welfare of the human subjects involved in FDA regulated research 
What is a Clinical Trial Data Monitoring Committee (DMC)?
A clinical trial Data Monitoring Committee (DMC) is a group of individuals with pertinent expertise that review on a regular basis accumulating data from one or more ongoing clinical trials. The DMC advises the sponsor regarding the continuing safety of trial subjects and those yet to be recruited to the trial, as well as the continuing validity and scientific merit of the trial  There has been an increasing use of DMCs in industry sponsored clinical trials even though current FDA regulations do not impose requirements for the use of DMCs in trials except for research studies in emergency settings in which the informed consent requirement is excepted. Several factors such as concerns of Institutional Review Boards (IRBs) regarding ongoing trial monitoring and patient safety in multicenter trials, increasing collaboration between industry and government in sponsoring major clinical trials performed under the policies of government funding agencies which often require DMCs. 
Does FDA recognize ISO 14971? What are the differences between ISO 14971 and ICH Q9?
The US Food and Drug Administration (FDA) has recognized the newly revised International Organization for Standardization (ISO) risk management standard for medical devices, ISO 14971:2019, along with more than 100 other consensus standards.   When comparing ISO 14971 to ICH Q9 it is observed that the process formality of ICHQ9 depends on the risk level whereas the ISO standard process is consistent across all medical devices. ISO 14971 provides detailed instructions on how to handle risks that have low probabilities of occurrence and how a manufacturer should handle a situation when it believes the risks have been mitigated as far as possible.   During the risk review process ICHQ9 recommends a much larger amount of information come from the manufacturing process, while ISO 14971 has a stronger focus on the user requirements.  
What is Health Hazard Analysis?
The Health Hazard Analysis/Assessment is used to systematically identify and evaluate health hazards, evaluate proposed hazardous materials, and propose measures to eliminate or control these hazards through engineering design changes or protective measures to reduce the risk to a level acceptable to the customer. 
Whose responsibility is to determine the causality of Adverse Events?
When a Serious Adverse Event (SAE) occurs, the site investigator needs to report the event to the sponsor. Both the site investigator and the sponsor assess causality for every SAE. Causality is whether there is a reasonable possibility that the drug is the cause of the SAE. The three criteria for causality are: 1. empirical association 2. temporal priority of the independent variable and 3. non-spuriousness. The FDA believes the sponsor can better assess causality as they have access to SAE reports from all sites and studies along with a familiarity with the drug’s mechanism of action. When expedited SAE reports are delivered to the FDA the sponsor determination of causality is reported.  If causality assessments differ between the site investigator and sponsor, it is important to understand the difference in assessments to ensure proper reporting and conduct through a trial. For example, if stopping rules rely on causality the protocol should state whether the sponsor’s or site investigator’s causality assessment is to be used. In addition, US requirements differ from ICH E2A. The E2A requires both the sponsor and the investigator to determine causality and the most conservative decision is reported.