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 Ministry of Health and Family Welfare, India, has granted approval to making the accreditation of Ethics Committees (ECs), involved in supervision of clinical trials, mandatory with effect from 01-Jan-18. The National Accreditation Board for Hospitals &...
ADAMAS was born (officially) on 1st September 1997, the year when the ‘new’ ICH GCP Guidelines were released – a happy coincidence in fact! Looking back, I can hardly believe we have been in business this long, and we’re still growing and expanding, which is the sign...
ADAMAS Consulting started on 1st September 1997 with five full-time auditing staff, based in the UK, but operating globally. ADAMAS’s business goal was “to become the global independent pharmaceutical Quality Assurance service provider of choice” – so how have we...
ADAMAS Consulting’s APAC Director, Shehnaz Vakharia, will be taking part in a panel discussion on “Quality and Safety Considerations in Clinical Development: Identifying ideal clinical sites and strategizing patient recruitment and clinical sites management in India...
About ISCR Conference Indian Society for Clinical Research has announced its 8thAnnual Conference, to be held during February 13-14, 2015 at Hotel Leela Ambience, Gurgaon. In keeping with the conference theme, 'Clinical Research in India - Towards Achche Din' the main...
India, with its large disease burden and experienced medical professionals, has been actively contributing to the global drug development, for more than a decade. However, the recent changes to regulations, although intended to safeguard patient rights and ethics, has...
With 56% of the world’s population residing in Asia, it is an attractive destination for clinical trials. However, maintaining the quality and integrity of the clinical research data in the emerging markets has always been a challenge for the pharmaceutical,...
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