The pharmaceutical industry plays a crucial role in the development and distribution of drugs that save and improve the lives of millions of people worldwide. The industry is constantly evolving and is heavily regulated to ensure the safety and efficacy of these drugs. Scientific affairs in the pharmaceutical industry refer to the various activities that are conducted to ensure that the drugs developed and marketed by the industry are based on sound science and are in compliance with regulatory requirements.
One of the main roles of scientific affairs in the pharmaceutical industry is to provide scientific support for the development, registration, and post-approval activities of drugs. This includes conducting research and studies to understand the safety and efficacy of drugs, as well as providing scientific advice to regulatory agencies. For example, a company may conduct a clinical trial to test the safety and efficacy of a new drug, and then submit the results to the Food and Drug Administration (FDA) for approval. The scientific affairs team would be responsible for providing the FDA with the necessary information to support the approval of the drug.
Another important aspect of scientific affairs in the pharmaceutical industry is the dissemination of scientific information to healthcare professionals, patients, and other stakeholders. This includes providing education and training on the safe and effective use of drugs, as well as providing updates on new developments in the field. The scientific affairs team may also work with key opinion leaders (KOLs) in the medical community to provide them with the information they need to make informed decisions about prescribing drugs.
In addition to these activities, scientific affairs in the pharmaceutical industry also plays a key role in the management of risk and safety. This includes monitoring the safety of drugs once they are on the market, as well as working with regulatory agencies to identify and mitigate any potential risks. For example, if a drug is found to have a potential side effect, the scientific affairs team would work with the regulatory agency to investigate the issue and take appropriate action to protect patients.
The pharmaceutical industry also heavily relies on intellectual property (IP) protection to secure their investments in drug development and bring new drugs to the market. Scientific affairs teams are responsible for protecting the IP of their companies by filing patents, trademarks, and copyrights on new drugs and technologies. They also monitor the market for potential infringement of their IP and take appropriate legal action if necessary.
In recent years, there has been an increased focus on the role of scientific affairs in the pharmaceutical industry in supporting sustainable development and corporate social responsibility (CSR) activities. Companies are now expected to not only consider the financial and clinical aspects of drug development but also the ethical and societal implications. Scientific affairs teams are now often involved in CSR activities such as providing access to drugs in low and middle-income countries and supporting health education programs.
Scientific affairs in the pharmaceutical industry plays a vital role in ensuring that drugs developed and marketed by the industry are safe and effective. They conduct research and studies, provide scientific advice to regulatory agencies, disseminate scientific information, manage risk and safety, protect intellectual property and support sustainable development and corporate social responsibility activities. As the industry continues to evolve, the role of scientific affairs will become increasingly important in ensuring that the drugs developed and marketed by the pharmaceutical industry meet the highest standards of safety and efficacy.
The Novum Advantage
What We Do
Protocol Development involves experienced professionals from the area of clinical sciences, medical and biostatistics to develop protocols to evaluate the required endpoints and apply appropriate statistical test to meet regulatory requirements for pharmacokinetic, pharmacodynamic and clinical efficacy studies. Our teamwork provides the resources necessary to develop protocols for new chemical entities, new indications and to develop innovative study designs.
Biostatistics and programming is a team of experts who are part of every clinical study, contributing from study design through compilation of a CDISC compliant report.
Biostatistics services include:
- Input into study design and sample size calculations
- Consultation during protocol development
- Generation of randomization schemes
- Assist in preparation of Statistical Analysis Plans (SAPs)
- Biostatistical analyses, including PK, PD, and efficacy data
- SAS Programming of Tables, Listings and Figures (TLFs)
- Quality Control of TLFs
- Input into the Clinical Study Report (CSR) for regulatory submissions to FDA, EMA and TPD
- Preparation of CDISC data sets (SDTM and ADaM)
Scientific Writing is a collaboration of our protocol and report writers, experts in field of medical and clinical sciences, clinical project managers and biostatisticians. They understand the importance of this phase of the clinical research process and are skilled at interpreting the data and presenting the results of the study.
- All reports are structured for submission to global regulatory agencies.
- Experienced team ensures that reports are prepared to FDA, EMA and TPD standards for NDA/ANDA submission.
- Clinical reports are created to comply with eCTD requirements in a submission ready format.