Drug Development
​THERAPEUTIC EXPERTISE....
Preclinical, Phase I, II, III, IV & Post Market Surveillance
Developing a new drug to help treat diseases is an expensive, complicated and time-consuming process, and project to manage. It can take up to 15 years, and costs over $2.5 billion. Hence, you can't afford to waste time in any part of the process, or phases of the trials. You need a professional or a firm, you can trust.
Our clients entrust us to help them progress their clinical trials. Our founder's years of experience in the industry, has helped the firm form a professional alliance with other clinical research professionals, who also have years of expertise in the industry. Her experience together with our partners equipped TMEP to provide expertise in therapeutic areas in large drug disease markets such as hematology/oncology and chronic conditions, R&D innovation, such as immuno -oncology, cell and gene therapy, biomarkers and rare diseases drug development.
We have extensive CITI GCP training. We also have GMP, and GLP training, which help us to successfully managed all phases of a drug development from preclinical to phase I, II,III, IV / post marketing monitoring, auditing and all regulatory activities including commercial GMP sites and data validation.
In every phase of the drug development process, TMEP has the expertise you need to design, plan, execute, and control risks in your clinical trials to obtain quality data integrity.
Drug Development Clinical Trials?
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Companies cannot market new drugs, medical devices, or biological products, without providing to the U.S. Food and Drug Administration (FDA) proof that the product is safe. Clinical trials are conducted to show safety, and efficacy of the product. Other countries, also have regulatory agencies that require similar proof of new drug safety and efficacy.
Regulatory agencies assess the information and data provided by sponsors and investigators, and then decide to approve or reject the marketing application for the product.
The International Council for Harmonization (ICH) E6 standards, has been implemented in the U.S., Europe, Japan, and other countries, to aid in compliance with regulatory requests of many of governmental regulatory agencies.
ICH E6 R1, and its 2016 addendum R2, relates to conducting clinical trials of drugs, medical device and biologics that abide by Good Clinical Practice (GCP) standards. Like many other to regulations and policies, the ICH E6 guidelines are periodically reviewed.
While many believe that most sponsors are academic and institutional entities within the Biotech / Pharmaceutical industry, that is not always the case. There are also individual investigators, who are sponsors and can also seek FDA approval to study an investigational drug or device. They are known as sponsor-investigators. Sponsor investigators are also required to follow regulatory guidelines just like all investigators and research sponsors.
The Pharmaceutical, Healthcare and Biotechnology industry conduct clinical trials for many different purposes. The number one objective of clinical trials is to show the safety and efficacy of the product, to obtained Food and Drug Administration (FDA) approval. However, there are many clinical trials that are for academic purposes and are not conducted for FDA submission. Nevertheless, those trials are still required to follow FDA And GCP guidelines.
FDA assist researchers on what constitutes as an acceptable clinical trials and appropriate outcomes. However, following FDA regulation is not enough. Hence, many Sponsors and contracted CRO's prefer following ICH GCP guidelines in combination with FDA guidelines to conduct research trials. It is important to note that ICH GCP guidelines are merely a standard in the US and not an enforceable law. Nonetheless, all sponsors require their trials to be conducted in a manner that follows both FDA and ICH GCP standards.
GCP standards are broader than FDA guidelines. ICH, 2016 E6 GCP guidelines, Section 5.0 states that the sponsor should create a system to achieve quality in all phases of the clinical trial. The quality management system should use a risk-based method. This was an essential change for trial monitoring, that extends beyond just routine periodic record auditing. For example, the new ICH E6 integrated addendum (R2), requires sponsors to implement a risk-based process that identifying risks in the study. Sponsors are also required to perform a root case analysis and also CAPA, Corrective Action and Preventative Action when needed.
Section 4.9.0 of ICH E6 also requires the investigator to sustain adequate and accurate source documents and trial proceedings including all related notes on each of the site’s trial participants. Paper, or electronic source data must follow ALCOA-C. This means it needs to be attributable, legible, contemporaneous, original, accurate, and complete. Any changes to source data should be traceable, it shouldn’t obscure the original entry, and must explained if needed.
ICH E6, Section 5.5 and FDA regulations are equally in agreement that the sponsor is accountable for the trial managing, data management, and record keeping. ICH E6 Section 5.5.3 further states that the sponsor must confirm that the electronic trial data handling and/or remote electronic trial data systems follow the sponsor’s written requirements for completeness, accuracy, reliability, and are validated. Written requirement should be a written standard operating procedure also know SOPs.
It is the responsibility of the Sponsor's / CRO's to hire a Clinical Research Professionals who are very experienced in other areas to maintain cost.
Contact us to not only perform monitoring, and auditing your study trials, but to also validate all your regulatory electronic data.