Life Science Industry

The complex process landscapes that have developed over the years to support clinical studies and the supporting IT systems have become increasingly fragmented. From setting up the clinical protocol to study setup and conduct in the EDC and CDMS systems, coordination in the CTMS and evaluation of the data in statistical tools - many solutions are involved and associated with a large number of redundant tasks due to suboptimal integrations and manual interventions.

Legacy systems and these fragmented tool landscapes challenge clinical innovation. A structured, forward-looking approach is essential to fully unlock the potential of digital transformation. Therefore, we reduce complexity of clinical operations by transforming system landscapes and aligning digital strategies with clinical and regulatory requirements. This enables faster data-driven decisions and ultimately leads to an enhanced patient experience. We support life sciences companies in evaluating, rethinking, and upgrading their clinical processes and IT infrastructure to accelerate time-to-market and increase early visibility into the probability of success – always with a focus on regulatory compliance, operational efficiency, and patient experience.

Inconsult offers comprehensive support in transforming your clinical processes – strategically and sustainably.

For the development, manufacture, marketing and sale of new products, companies must obtain approvals or be able to assume in advance, for example during the development process, that they will receive them. The often complicated approval procedures are managed in the regulatory affairs departments of our clients in the pharmaceutical and cosmetics industries. We support our clients here in the following areas:

• New Drug Application
• LifeCycle Management
• Labeling & Artwork Management
• Data Management (xEVMP, IDMP/SPOR)
• Document & Submission Management

We provide support in numerous areas where information technology is used in pharmaceutical production, including the manufacturing, packaging, storage and distribution of pharmaceutical products. Inconsult ensures that IT systems meet the high demands of the industry and that production runs smoothly.

Inconsult offers a wide range of services:

• Consulting and support in the implementation and validation of IT systems such as Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS) and Data Historians.
• Providing IT support and training for pharmaceutical manufacturing staff.
• Ensuring compliance with regulatory requirements, such as FDA requirements in the USA or GMP requirements in Europe.
• Conducting audits and implementing measures to improve production processes.

We also support our customers in modernizing their quality management under the aspects of maintenance/improvement and "cost of" compliance.

We advise you on all aspects of quality and risk management. 

In this context, we support and advise you in setting up QM systems or review already established systems. In addition, we conduct audits and trainings and develop efficient and practical QM concepts as well as assist in the digitalization of processes such as:

• Corrective and Preventive Action (CAPA)
• Change Management
• Deviation Management
• Complaint Management

All activities related to the detection, assessment, understanding and prevention of adverse drug reactions or other drug-related problems are summarized under the term pharmacovigilance.

This area is highly regulated by appropriate regulatory requirements and is regularly audited by the authorities. We support our customers in essential aspects, such as the (semi) automated preparation of:

• Global and local Pharmacovigilance System Master Files (PSMF)
• Safety Update Reports (DSUR/PSUR)
• Periodic Benefit Risk Evaluation Reports (PBRER)

In addition, AI-based systems are used to process adverse drug reaction reports (ADRs) and our customers receive support during regulatory inspections.

Innovative medicines often require a great deal of explanation in order to be used appropriately.

The "Medical Information" department of our customers supports members of the medical profession, such as physicians, pharmacists and health care professionals. However, lay people are also advised on responsible and competent decision-making before and during drug therapy.

We support our customers on request with modern technology, such as chatbots, systems for machine translation of pharmaceutical texts, AI-supported question & answer systems, to provide up-to-date medical-scientific information on drugs and their therapeutic areas.