IT Solutions

Don’t rely on CROs to handle your data in their own, managed systems. Allow us to help implement your own solutions to maintain complete control of your own data.

We work with AgosIT to offer cost-effective, fully validated solutions that enable small and medium sized Pharma’s and Biotech’s to manage GxP systems much earlier than they otherwise could. Not only can AgosIT select, validate and maintain your system, but Agos Pharma and AgosIT can facilitate data input on your behalf.

AgosIT partner with a range of selected industry-specialized software developers. This allows us to work with you to select the systems that fit your organization’s needs, not the other way around. We can host GxP systems that enable cost-effective, regulatory compliant solutions for every type of client.

For more information on AgosIT’s specialized IT solutions, visit agosit.com.

QA

From audit to gap analysis to inspection preparation, we can help you be prepared.

We can create documentation from individual SOPs to full QMS systems.  Together with our AgosIT colleagues, we can either host an eQMS for you, or select, implement, validate and run your own inhouse eQMS.

Pharmacovigilance

During the initial stages of drug development, you may be tempted to leave your safety data on CRO databases because of the cost and complexity of obtaining your own system.  This gives away control and leaves you open to problems with aggregate reporting, differing processes, quality levels and costs and issues when you want to bring the data in-house or transfer to another CRO.

We can help you select, implement and validate your own in-house pharmacovigilance database, or offer a hosted solution where you keep control of your data.

Allow us to work with our AgosIT colleagues to ensure you can have complete control of your data right from first into human.  We can work with multiple CROs to harmonise your safety data and keep it all in one place, with high quality, highly compliant, cost-effective pharmacovigilance processes.

Clinical Development

Do your systems talk to each other?  Are your staff wasting time managing separate systems? Do you have genuine oversight of what your CROs are doing?

It is often tempting to leave data on multiple CROs systems and/or keep track of things on excel spreadsheets.  This can lead to problems with oversight, tracking of studies and, later on, in bringing data in-house,

We believe in allowing you to keep full control and oversight, whilst we can give you all the support to keep your workload down.

We can work with our AgosIT colleagues to either fix your existing systems, or help you select, implement and validate the most appropriate and cost-effective IT solutions.  This includes Clinical Trial Management Systems (CTMS), electronic Trial Master Files (eTMF), Electronic Data Capture (EDC) systems and Electronic Quality of Life Questionnaire (Electronic forms).

Regulatory

We are well aware of the increasing demands in terms of tracking regulatory documentation, often with multiple users in different locations, whilst meeting the requirements of data protection, for example via the General Data Protection Regulation (GDPR) in the EU.

We can help select, implement and validate a Regulatory Information Management System (RIMS).  And, because we have both IT expertise in AgosIT and experienced regulatory experts inhouse, we can give all the support you need in maintaining the system.

Named Patient Program Portal (NPPP/ EAPP)

Our AgosIT colleagues have experience and expertise in selecting, implementing, validating and maintaining systems to aide Early Access and Named Patient programs.  We can not only sort the IT needs to reduce your workload and ensure compliance, we can Project Manage and Implement the whole process for you, ensuring appropriate management from Healthcare Professionals, through Regulatory and Safety requirements to the patient.


2020 © Agos Pharma All rights reserved.