Astrum

Our ‘Adopt a CRO’ service can deliver a Clinical research profile on your team (Medical Monitor Biostatistician, Regulatory Affairs, Project manager, etc.). The aim is to support your development plan/strategy and turn your ideas into a study synopsis or clinical project.

Founders or Chief Medical Officers of Biotech or Medtech companies in particular will be motivated by gaining access to all our competencies for a very affordable fixed monthly price.

We provide tools, resources, networks and advice for your project, delivered in an efficient, affordable, and simple way.

We offer both scientific and administrative support with the Data and Safety Monitoring Board to ensure the review and evaluation of trial safety and efficacy data is successful and meaningful.

This includes:

• Administrative support (i.e. organization of the DSMB meetings incl. meeting minutes, help on finding DSMB/IDMC members, contracts etc.)
• Scientific/statistical input (i.e. medical review of safety data, preparation of DSMB charter, reporting of outputs for DSMB/IDMC review and independent statistician attendance to the meetings.
• Connecting you with experts to be part of the DSMB.

At Astrum, we have established a clinical investigative site network that streamlines the collaboration during start-up and ensures contribution by the site to the study.

Through this model, we operationalise the clinical research activity in partner health institutions, promoting its development, efficiency, and excellence. The CRP acts as a Site Management Organisation, helping to coordinate the clinical research activity of partner hospitals.

To manage the recent delegation of skills in the Health industries, companies need expertise, granular knowledge, and a customisable service with a fixed or limited duration optimally tailored for them.

We offer a dedicated department providing skills in Clinical Development, Regulatory and Pharmaceutical Affairs, Scientific and Medical Affairs, Pharmacovigilance, Market Access, Biometrics, and Quality Assurance.

As part of our commitment to decreasing the burden on trial participants, we offer an extensive service of home nursing. Working with over 150 ICH, GCP, and IATA-trained nurses, we offer home nursing with a wide array of services including drug administration, support with home medical devices, sampling, questionnaires, and many more.

We provide statistical services in the “AMNOG procedure”, named after the “Arzneimittelmarktneuordnungsgesetz“, which is the German HTA procedure for medicinal products.

The AMNOG provides the benefit assessment of reimbursable medicinal products with new active ingredients based on proof provided by the pharmaceutical company. This also applies to newly authorised indications of these medicinal products.

We support the management of reimbursement of patient travel costs for Sponsors.  Depending on your current working practices, we offer multiple solutions either through traditional tracking or via our innovative digital solution.

Our digital solution provides patients with a payment card and a private bank account. The investigator sites and sponsors will assign and confirm patient reimbursements through an online and user-friendly platform.

Our tool reduces the administrative burden on patients and sites, increasing the engagement, motivation, and retention of all parties in your clinical study.