As part of the pharmaceutical industry, you have to face a variety of challenges every day that can be solved by modern pharma software solutions. The ever-rising pressure to innovate due to the highly dynamic competitive market urges pharma companies to seek innovative tech partnerships. The short product cycles while complying with all international laws and pharma regulations is another major challenge within the pharma industry.
Working in a bespoke software development company focused on the pharma sector, I know the value of optimised product management, improved transparency and optimised IT infrastructure. However, as one of the most strictly regulated global industries, the pharma sector could only benefit from a refinement of ongoing operational requirements that take up lots of time and manual labour, e.g. documentation, drug rollout, communication between representatives or clinical trials.
Pharma Software Solutions for Clinical Trials
Pharma companies can’t simply bring new medicines onto the market. Instead, they have to meet the precise requirements of the national and international regulatory authorities during drug development. As a rule, a new active ingredient is first tested in the laboratory, and then animal experiments are carried out. Before each drug receives approval, it needs to undergo numerous clinical trials to prove its effectiveness on people. As procedures, clinical trials require strict time management, team collaborations, law compliance and cost optimisations. Pharma software solutions are an indispensable way to ensure each step of the process is done right.
Here are the four internationally approver phases of clinical trials and how pharma software solutions can help solve the challenges:
The new drug is introduced to people for the first time. The test subjects are usually pre-selected young, healthy men, and their participation helps researchers determine how the human body reacts to the drug. A well-thought-out software solution developed by experienced healthcare software developers can help pharma companies select suitable candidates as well as with protocolling the results and team coordination. According to FDA statistics, nearly 70% of drugs continue to the next phase.
Here, the number of people is increased to several hundred, meaning more people will receive the drug. For successful research, clinical trial participants need to have certain health conditions that could be treated with the new drug. Depending on the type of drug, several hundred people are often examined at this stage. The general aim of the second phase is to prove efficacy and outline possible side effects, and approximately 33% of newly developed drugs pass Phase II. Intelligent pharma software solutions can help clinicians with drug administration procedures, adherence to documentation, remote patient monitoring and data analysis.
Depending on the type of drug, several hundred people are often examined at this stage. Only cancer drugs or other medications expected to have severe side effects are administered to sick patients during all four phases. This third phase can take up between one and up to four years to provide reliable results. Between 25 and 30% of all drugs pass this third phase. In Phase III, some pharma companies partner with CROs (Contract Research Organisations) that help them with test implementations, field expertise and result interpretation. To fill in any communication gaps and help mitigate risk factors, these organisations utilise cutting edge technologies such as data mining, segmentation software solutions or AI-driven communication tools that boost patient engagement.
The final clinical trial phase only takes place after a drug has been approved for the market. The product can, therefore already be sold legally for treatment at this point in time. This phase is usually about observing the drug’s safety and side effects as well as discovering potential new use cases. Depending on the various needs, pharma software solutions can ensure remote patient monitoring, drug personalisations, protocol validations, as well as legal preparations regarding impending drug rollout.
Pharma Software for Digitalisation of Drug Rollout
Pharma expert Gary Connors thinks that the real challenges ahead of pharma companies go in direction of cost optimisation and accelerated drug development. Then, he asks if, for every $100 billion invested in pharma products each year, only 30 new drugs enter the market, how could the pharma industry reach 300 new drugs per year? Many people still wonder how Covid-vaccines were developed in only 18 months but perhaps the most helpful question is how can the future drug rollout process be shortened. Put simply, by utilising all capabilities of modern software technologies that ensure data privacy, security and compliance.
To answer these pharma needs, new technologies help dramatically optimise the drug development process by automating most manual processes such as documentation, approvals, compliance adherence and digitising overall workflow to reduce labour costs and improve cost-effectiveness. While using pharma software solutions with AI or ML components that make precise predictions of how molecules interact with each other, pharma companies can substantially decrease the years of trial and error that make the development process so difficult. Also, the drug rollout process can be optimised by investing in pharma marketing solutions and reliable communication platforms between sales representatives and doctors.
Pharma Software Solutions for Ensuring Compliance
The pharmaceutical industry is one of the highest regulated markets in the world and companies need to ensure their internal processes are always compliant with industry standards and national and international regulatory requirements. Providing a secure place to store all privacy-compliant data, pharma software solutions can offer platforms for data management, documentation automation, in-built alert and notifications with important deadlines and so much more.
Depending on the country, pharma businesses need to comply with different standards and national authorities. For example, in the USA, the active pharma regulations include FDA approvals and HIPPA requires companies to work with protected health information to implement and follow physical, network, and process security measures. In Europe, the agency responsible for drug control and rollout is EMA, while the active regulation act regarding data security is GDPR. Similarly, in the UK, there are other regulatory bodies and active compliance directives, e.g. DHSC, MHRA or MDD. By choosing to partner with a bespoke software development vendor, pharma companies can rest assured that their full spectrum of compliance needs is taken care of.
Author Biography Aleksandrina Vasileva
Aleksandrina is a Content Creator at Dreamix, a custom software development company, and is keen on innovative technological solutions with a positive impact on our world. Her teaching background mixed with interests in psychology drives her to share knowledge. She is an avid reader and enthusiastic blogger, always looking for the next inspiration.