Regulators | Molecular Health

Regulators

Enhanced pharmacovigilance through clinico-molecular insights

Although clinical trials are instrumental to making drugs available to patients, their evidence is generated under highly controlled conditions – excluding patients that may receive the therapy in real life. Molecular Health helps you assess and predict the real-world safety profile of new and approved drugs, by combining traditional pharmacovigilance approaches with new innovations in mechanism-based assessment and prediction.

Regulators

Enhanced pharmacovigilance through clinico-molecular insights

Although clinical trials are instrumental to making drugs available to patients, their evidence is generated under highly controlled conditions – excluding patients that may receive the therapy in real life. Molecular Health helps you assess and predict the real-world safety profile of new and approved drugs, by combining traditional pharmacovigilance approaches with new innovations in mechanism-based assessment and prediction.

Use real-world evidence to improve drug safety assessment and prediction

It is difficult to fully vet the safety of new therapies. In fact, some serious – or life impacting – reactions may not arise until the drug has been widely prescribed. Molecular Health’s solution combines real-world data from millions of patient safety reports with molecular data on how drugs function at a molecular level within the body, so regulators can come closer to accurately assessing what should be on the label – including unexpected interactions with comedications and comorbidities.

Enhance analysis of AE causality

Combine traditional pharmacovigilance with innovations in mechanism-based assessment for novel insights into the molecular causality of drug safety issues and to transform the accuracy and speed of your drug labeling decisions.

Predict drug safety labels

Combine traditional pharmacovigilance with innovations in mechanism-based prediction to identify potential safety issues for new and approved drugs. Using MH Predict, you can anticipate and predict important/designated medical events before they occur.

Augment analysis of drug-to-drug interaction

Molecular Health provides you with a new dimension of insight into drug interactions so you can move beyond established knowledge to identify novel interactions in targets and pathways, as well as clinical co-morbidities.

The only thing worse than failing a promising drug for safety concerns is approving a drug that exhibits dangerous side-effects in-market. Molecular Health can help you determine the safety profile more efficiently and with greater accuracy.


Risk Icon

For diseases that tend to have comedication, or comorbidities, a lack of molecular insight makes unexpected adverse events possible. Molecular Health provides insight to the effect of these problems in the real world.



Profiling Icon

It is not easy to cross reference drug effects across classes, indications and labels to ensure most effective pharmacovigilance. Molecular Health aggregates and interlinks all available safety evidence in one intuitive application. 



Profiling Icon

Our powerful applications for decision support


Molecular Health Guide (MH Guide) identifies safe and effective therapies for patients by analyzing the molecular profile. It matches detected mutations to the world’s knowledge in the field of oncology and hereditary diseases and helps medical experts to create a patient-specific clinical report. MH Guide is an IVD registered in the EU.

MH Predict Logo


Molecular Health Predict (MH Predict) is an application to predict clinical trials probabilities of success. It enables the improvement of clinical trial success and reduces clinical trial failure while optimizing resource allocation for the biopharma industry and investors and enhancing the overall efficiency of drug development.

Protecting your personal data is a critical issue in our eyes
Both self-paying and reimbursed patients or those whose employers offer the Corporate Oncology Program for Employees (COPE) can rest assured that none of their personal information is communicated to the company. Only the treating physician and the MH certified physician have access to personally identifying patient data. Molecular Health works exclusively with pseudonymized data; no personal information is conveyed or saved.
Read more

Let’s talk about how our technology can work for you

To find out more, you can call our customer care team or help desk or send us an e-mail. We would be delighted to provide you with more information or answer your questions.


EU: +49 6221 43851-150
E-Mail: CustomerCareEU@molecularhealth.com