As a transparency initiative for public disclosure of clinical trials, the FDAMA of 1997 for voluntary registration of clinical
study protocols laid the foundation of Clinical trials registry databases. In 2004, ICMJE announced that there will be no
publication for any clinical trial results which had not been prospectively registered in a publicly accessible database. On
September 27, 2007, Title VIII (Clinical Trial Databases) of FDAAA made the registration of clinical study protocols mandatory,
added mandatory results and adverse events reporting.
Clinical Trial Disclosure at SIRO
SIRO has partnered with major clients for more than 3 years to support and ensure compliance of their clinical trial disclosure
requirements as per FDAAA and Client SOPs.
SIRO Team for Clinical Trial Disclosure
- Public disclosure of study protocols and results at various registries across the globe e.g.
Clinicaltrials.gov, EudraCT, German registry and CTRI
- Proficiency in clinical trial protocol registration and results disclosure for studies of
varying complexity, phases and therapeutic areas e.g. virology, oncology, neuroscience, immunology, cardiovascular, metabolism
- Capability to handle end-to-end trial disclosure process including writing of documents with comprehensive
coordination with stakeholders of trials and posting of trial data at various registry databases
- Multidimensional Training modules with cross therapeutic areas training
- Results driven quality metrics which helps us to deliver and maintain excellent quality trial disclosure
documents in the required timeframes
- Well trained medical writers to understand, analyze and summarize complex scientific data into quality disclosure documents
by working on either software database containing data fields corresponding to registry requirements or word documents
Few client testimonials which tell the story of building trustworthy relationship with our clients
- Successful collaboration for over 2 years with one of Top 10 Pharma companies for Clinical Trials Disclosure activities
- Clinical trial disclosure tasks of over 250 protocol registrations and 80 basic results posting have been accomplished
within stringent submission timelines
- SIRO's experience contributed to aligning client's clinical trials software database fields as per the data elements of
clinicaltrials.gov, creating exceptional software database for clinical trials disclosure activities for our client
- "SIRO has been a valuable partner of Clinical Registry disclosure activities"
- "The writers are well-organized, cooperative and diplomatic. Their coordination is sharp and constructive. We also see
commitment, responsiveness and motivation from all members of the team."
- "SIRO team continues to act proactively and in a transparent way which is much appreciated"