Pharmaceuticals

Solutions in the field of conflict of creativity in research

Benefit from our experience gained in the areas of research and development (R&D), clinical testing, sales and marketing consultation as well as the design and development of optimal systems in regulated and unregulated environments (including GxP, GAMP 5, CSV). We always use the very latest technologies such as artificial intelligence (AI), blockchains, open source frameworks or Microsoft. We will also assist you in your merchandise management system (securPharm or MSV3) solution development and will help you to validate these systems for GDP (Good Distribution Practice) and MDR (Medical Device Regulation).

IT

Like most other sectors, digital transformation is also having an impact on the pharmaceutical industry. We will work with you to determine the level of digital maturity of your company or we will help to set up a digital workplace. Furthermore, take advantage of the potential offered by digitalisation and use a BI/BA strategy to draw the right conclusions from the data you have acquired. Invest in the development of AI solutions or optimise your recurring processes using process automation.

Digital leader – on the path to digital mastery

Are you faced with the task of realigning your company against the backdrop of digitalisation? With our digital readiness check, we can accompany you on the way to digital mastery. It makes no difference whether your company is a ‘digital beginner’ or whether your company is already on its way to digitalisation.

adesso uses a tried-and-tested and scientifically based assessment for determining your level of maturity when it comes to digitalisation. The result is an assessment of the status quo that can be used to determine tailor-made activities for achieving and implementing your digital vision. Our digital readiness check provides you with specific recommendations for drawing up a rough transformation plan. This is supplemented by an analysis of your self-image concerning ‘where you are now’. Afterwards, you have the opportunity to implement the necessary measures on the basis of individual modules in accordance with the transformation plan.

Shape the digital workplace of the future now

Present yourself as a modern company with up-to-date digital working methods, involve your customers and patients in your processes and make your regulated process workflows transparent.

adesso will make it possible for you to enter the digital workplace, no matter whether you are interested in the optimisation of processes in a regulated environment, change management for a new digital workplace or the optimal use of technology. With our process model, we can ensure transparency throughout the entire process, guarantee you maximum security and enable easy access via a predesigned discovery phase.

We do not only focus on technologies – your employees, customers and individual processes are at the centre of what we do, no matter whether we are at the stage of developing a clear strategy, creating a reliable roadmap or carrying out the final implementation. In doing so, adesso takes into account all the relevant regulatory requirements.

Predictive analytics, big data, data science and more

Reap the benefits offered by digitalisation and gain knowledge from the data you have acquired. We will help you to prepare your data for clinical studies, market observations or your individual services. Use master data management to improve the quality of your data.

adesso provides you with the latest business intelligence solutions on the predictive basis of structured and mainly operational data. You can also benefit from our business analytics solutions for acquiring information from unstructured or poly-structured data.

Our experts combine expertise from the area of bioinformatics with artificial intelligence (AI) in order to provide you with powerful data collection processes. This way, we can guarantee you the high-quality preparation of your data, for example, through the use of a data lake. adesso will also help you to renew and modernise your BI architectures so that you can use streamlined and agile approaches throughout the ‘data world’ of your company.

adesso has data scientists who are experienced, above all, in issues to do with Life Science. Our Interaction Room method allows us to design and implement your planned projects together with you.

Expertise meets AI

The advantages of using artificial intelligence (AI) speak for themselves:

  • You can use it to relieve the workload on your service departments, for example, by using chatbots.
  • You can increase the satisfaction of your customers across various channels.
  • You can support doctors and specialists, who work in diagnostics, for example, by using medical products for automatic image recognition and processing.

Furthermore, when AI is used, clinical studies can be carried out faster and more efficiently. On the other hand, patients and service staff benefit because the products are easy to use.

adesso is your partner when it comes to developing ideas on the practical application of AI using innovative methods (such as the Interaction Room or design thinking) that also meet the relevant regulatory requirements. Thanks to IBM Watson, Microsoft AI, robotics, machine learning (ML), deep learning, text mining, natural language processing (NLP) or neural networks, we are able to draw on a technological repertoire that is complemented by our project experience in this area.

Benefit from our expertise in the use of internal and external data sources with the aid of AI in the R&D area and within product development. Our employees will help you to develop your AI strategy and organise a chief data officer.

Process automation across systems with RPA

Specific processes such as orders, requests or change notifications are things that need to be carried out at regular intervals. To save time and resources in these areas, you should consider introducing business process automation. By using this technology, you can increase your process efficiency (round-the-clock operation) and reduce time and costs as less personnel is required. At the same time, it allows you to be more flexible when it comes to implementing processes and you can respond more quickly to requests.

Our standardised and tried-and-tested process model uses specific ROI calculations to assess the opportunities for using RPA in your company. adesso will support you until your finished robotic process automation solution has been implemented. Our offering includes the following:

  • Advice on the automation of your processes, taking regulatory requirements into account.
  • The selection and provision of suitable tools.
  • The creation of a prototype for your individual proof of concept (PoC).

Our teams of experts combine process knowledge from the pharmaceuticals, medical technology and diagnostics areas with RPA experience gained from numerous customer projects successfully implemented with AI technologies as well as a tried-and-tested methodological procedure based on the Interaction Room.

Quality and regulation

Create your medical solutions more quickly and improve their quality. Take the necessary precautions to ensure that your IT infrastructure meets the requirements of the supervisory authorities for the good distribution practice of medicinal products. We will help you with this. We will also support you with the risk-specific optimisation of your development, documentation and operating processes and the introduction of process automation.

Process excellence thanks to modern application lifecycle management

Create your medical solutions more quickly and improve their quality. We will help you to optimise your development and documentation processes, taking into account all the relevant regulatory requirements. Our experts will create a solid foundation for the continuous further development of your solutions and for your ongoing operations and support.

Our competence in the area of application lifecycle management, combined with the use of maturity models in accordance with Medical SPICE, allow our project teams to determine the current level of maturity of your processes and show you the potential for development. In addition, we guarantee the optimisation of your processes and documentation according to GAMP5, CSV or ISO 13485, for example.

In addition to helping you select and integrate modern ALM tools, adesso will also assist you in implementing the appropriate processes and integrating agile process models. If required, we can also coach your teams or employees.

adesso has already provided coaching support to numerous well-known companies in the Life Sciences sector and helped them to introduce innovative ALM processes. We would be glad to speak to you in person and provide you with detailed references.

VALIDATION SUPPORT TO ASSESS THE OVERALL RISK AND IDENTIFY THE REQUIRED DOCUMENTS

Companies that are authorised to engage in the wholesale trading of medicinal products in accordance with section 52a of the German Medicinal Products Act are subject to inspections carried out by the supervisory authorities for the good distribution practice of medicinal products (GDP).

The current guidelines specified in the EU Official Journal of 5 November 2013 (2013/C 68/01) require computer-assisted systems to be validated in order to prevent possible harm to patients. This primarily concerns the merchandise management system as data for tracing batches is processed here.

adesso will help you to analyse your IT infrastructure, including your software systems, servers and clients as well as regulatory relevant processes, such as data backup and recovery, in order to identify potential risks and take appropriate action.

We will provide an assessment of the overall risk as defined in the GDP and will assist you in identifying the necessary documents. In addition, our experts will look at your relevant IT management processes, including your user management, data backup or incident management.

Our services include:

  • Process instructions/SOP (standard operating procedure) for computer system validation (CSV)
  • List of IT infrastructure used (validation master plan)
  • Process instructions/SOP for IT infrastructure
  • Validation plan and report for software systems (for example, merchandise management)
  • Risk analysis for software systems
  • Test plan and report for software systems

Exploit the opportunities offered by GxP compliance

GxP compliance is a must for pharmaceutical companies. Whether the risk-specific optimisation of development, documentation and operating processes is involved, the integration of new requirements from the areas of GAMP 5, CSV, GxP, 21 CFR Part 11, the EU GDPR or the integration of new technologies, the correct handling of these guidelines to ensure ‘good working practices’ offers you a wide range of opportunities. Therefore, use the individual manoeuvring room you have to optimally implement your specific requirements.

Thanks to our many years of experience in implementing regulated validation projects, we are able to offer you a validation consultancy service. In addition, adesso will accompany you up to the successful completion of validation in the laboratory, clinical, manufacturing and distribution areas, while taking into account the requirements of the FDA and EMA. Here, we use ready-made templates that ensure fast implementation and optimisation of your GxP processes.

We would be glad to speak to you in person and tell you about the projects that we have successfully completed for start-ups as well as large corporations.

The connection between the digital laboratory and data integrity

Digitalisation offers you the opportunity to reduce the personnel expenditure for routine activities in your laboratory. Manual tasks relating to the laboratory journal and the processes and interfaces between the systems used in the laboratory are automated. You can also improve the quality of data by identifying and eliminating process weaknesses, taking into account the data integrity requirements of the EMA (European Medicines Agency) and FDA (Food and Drug Administration).

If more extensive data is available to you from the laboratory and continually analysed with other external data sources using artificial intelligence (AI), a whole range of opportunities, ideas and practical approaches will open up for developing new active substances or products.

adesso combines professional expertise from the laboratory environment with extensive IT knowledge. This makes it possible to connect the interfaces between your systems in the laboratory on a procedural and technical level. During the digitalisation of your laboratory, we will take all the regulatory requirements of the FDA and EMA into account. This includes, for example, the FDA Guidance for Data Integrity and Compliance with cGMP or the MHRA GxP Data Integrity Guidance.

Our team of experts will look into – depending on you individual starting point – the design and use of IoT or Internet of Medical Things platforms for suitable integration into your laboratory.

adesso has already developed various platforms in numerous projects for the purpose of automating the communication and exchange of data between analytical devices for day-to-day operation as well as service and maintenance. We would be glad to speak to you in person and provide you with detailed references.

Research and Development

Avoid media disruptions and the loss of data quality by using direct interfaces to digital health platforms and health records or benefit from the opportunities offered by using artificial intelligence (AI). We will master these challenges together.

Get started with digital health platforms in the e-health sector

Avoid media disruptions and the loss of data quality. Direct interfaces to digital health platforms and health records are essential if you want to network perfectly with your partners. Acquire additional market and usage data for your products by developing new partnerships in regulated and unregulated healthcare environments.

Our teams combine professional expertise from the pharmaceuticals, pharmaceutical retail, medical technology and laboratory diagnostics areas with effective methods, such as digital mastery or the Interaction Room. We help you to cast your strategic components into suitable solution approaches so that you can implement your processes effectively. When implementing your digitalisation projects, such as medical products, Web solutions or medical apps, we take all the regulatory requirements of the FDA and EMA into consideration.

adesso has already brought numerous e-health and strategy development projects to a successful conclusion for laboratory service providers, medical technology suppliers and healthcare providers. We also maintain various partnerships with leading providers of digital health records and health platforms, such as vivy.

Expertise meets AI

The advantages of using artificial intelligence (AI) speak for themselves:

  • You can use it to relieve the workload on your service departments, for example, by using chatbots.
  • You can increase the satisfaction of your customers across various channels.
  • You can support doctors and specialists, who work in diagnostics, for example, by using medical products for automatic image recognition and processing.

Furthermore, when AI is used, clinical studies can be carried out faster and more efficiently. On the other hand, patients and service staff benefit because the products are easy to use.

adesso is your partner when it comes to developing ideas on the practical application of AI using innovative methods (such as the Interaction Room or design thinking) that also meet the relevant regulatory requirements. Thanks to IBM Watson, Microsoft AI, robotics, machine learning (ML), deep learning, text mining, natural language processing (NLP) or neural networks, we are able to draw on a technological repertoire that is complemented by our project experience in this area.

Benefit from our expertise in the use of internal and external data sources with the aid of AI in the R&D area and within product development. Our employees will help you to develop your AI strategy and organise a chief data officer.

Sales and marketing

Cater to your customers in a personalised manner over the complete sales and service cycle or use chatbots and self-service portals to make your service processes much more efficient. We will help you to introduce a customer experience management (CEM) system and assist you in shaping your ‘customer journey’ for the over-the-counter and Rx markets.

Focussing on the customer

In order to cater to your customers in a personalised manner over the complete sales and service cycle, you need to be aware of all aspects of your potential customers, identify the specific motives of your customers and prepare your content so that you reach your customers directly.

Use customer experience management (CEM) to achieve lasting customer satisfaction and, at the same time, support (within the scope of legal regulations) your sales processes through targeted marketing campaigns as part of multi-channel management.

With more than 15 years of experience in the pharmaceuticals, medical technology, laboratory and diagnostics areas, adesso will help you to shape your ‘user journey’ and assist you in designing and developing your solutions for customer management. This includes:

  • Extended relationship management (XRM)
  • Marketing and e-commerce
  • Service solutions based on standard software, such as SAP C/4HANA, Microsoft Dynamics CRM & Marketing or SalesForce.

In this way, you can specifically target your customers in the over-the-counter and Rx sectors as well as the medical technology area. To ensure you can maintain the relationships you have with your customers on a long-term basis, either via social media channels, social engagement activities or within your customer portals, we assume responsibility for the development and implementation of your individual relationship marketing strategy.

Customer service and e-commerce working together

You can make your service processes much more efficient by using chatbots and self-service portals for patients, doctors and other specialist groups. Increase the satisfaction of your customers by offering better and faster accessibility plus high-quality processing of requests and complaints. Also consider using e-commerce solutions to make the procurement process for your customers more intelligent.

We will assist you in shaping your ‘customer journey’ for the over-the-counter and Rx markets. Building on this, our experts will take care of the design and development of your individual services or e-commerce solutions based on standard software such as SAP C/4HANA, Microsoft Dynamics or Salesforce. At the same time, we will supervise the setup of a suitable reporting system that will allow you to continuously monitor performance and success and give you the option to make adjustments for the purpose of optimisation.

Thanks to our industry experience, combined with our deep understanding of the relevant processes in the service, sales and e-commerce areas, we have already implemented numerous projects successfully. We would be glad to speak to you in person and provide you with detailed project references.

Successful projects in the pharmaceutical industry

Do you have any questions?

Your contact person
Thomas Strong
Division Manage Life Sciences

+49 69 668157-224

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