At this moment the FDA Center for Devices and Radiological Health (CDRH), in collaboration with the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER), are planning to release a new guidance document entitled...
This piece is an extract of the upcoming ADAMAS white paper “Making the Model: Solving the Data Integrity Challenge of Decentralized Clinical Trials”. Data integrity is an essential element of any data handling task. It goes without saying that if data isn’t accurate...
No matter if you're preparing for an imminent clinical trial inspection or if you're just bracing for a mock inspection, it is vital for you and your team to be prepared. Even so, establishing a culture of readiness can be difficult with each step presenting its own...
At ADAMAS we have made a commitment to all our clients to ensure safe, accurate and secure retention of critical information relating to the services we have provided. For example, the final version of audit reports as well as the CV and Training Record of the...
There is no doubt you are aware of the UK’s intention to leave the EU on Friday 29th March 2019, and that following the planned departure, EU law – including those on medicinal products – shall cease to apply in the UK. Nevertheless, there are still ongoing...
Ministry of Health & Family Welfare, Government of India, has released the Pharmacovigilance (PV) Guidance for Marketing Authorization Holders (MAHs) and it will be effective from Jan-18. The guidance document intends to enable the MAHs to set up a PV system at...
As informed earlier in our blog, the Ministry of Health and Family Welfare, India, has mandated the accreditation of Ethics Committees (ECs), involved in supervision of clinical trials, with effect from 01-Jan-18. The accreditation will be conducted by National...
The Medicines and Healthcare products Regulatory Agency (MHRA) recently published their latest Good Pharmacovigilance Practice (GVP) Inspection metrics covering the period April 2015 – March 2016. Within this period a total of 35 inspections had been carried out,...
The ICH E6 (R2) has been formally adopted by the ICH assembly held in Osaka, Japan on 5-10 November 2016. All changes proposed in ICH E6 (R2) Step 2 have been accepted in principle, within the ICH E6 (R2) guideline during Step 4 adoption by the ICH Assembly. A...
Computer Software Assurance (CSA): Why the Change and What Does it Mean?
Annex 1 Revisions: What are the Changes and Whom will they Affect?
Why Is Data Integrity Important When Transferring Data in a Clinical Trial?
ADAMAS and Ergomed combine to expand global capabilities
ADAMAS Spotlight: Jean-Luc Salendre