Ascon Health approach to data management is precise and efficient.

Our teams develop clinical study specific data management strategies that are ambitious and innovative. Our systems are 21 CFR Part 11 compliants.

Our services include:

• Electronic data capture (Using Omincomm Trial Master™ & Trial Builder™)
• CRF & eCRF design
• Database design
• Data entry
• Data validation
• Medical coding
• Data transfer
• External clinical data integration and processing - Labs and Radiographs
• Online data access
• Formal data quality management

Ascon Health leverages OmniComm's EDC system for improved efficiency and data quality.

Trial Master™ & Trial Builder™ technology and our approach streamlines clinical trial data collection while maintaining very high data integrity while minimizing time during clinical trials.

Our "What You See is What You Complete" methodology caters to:

• Easy completion of eCRFs
• Efficient workflow at the clinical sites
• Work flow at the site for PI and site coordinator
• Easy training for PIs and site coordinators
• High acceptance at clinical sites
• Rapid start-up of clinical trial
• Easy customization for each trial
• Highly automated eCRF / template building
• In-built data quality edit checks
• Need for real-time data access
• Faster query resolution
• Lower error rates
• Quicker DB lock from last patient out (LPO)
• Access to individual patient status
• Seamless SAS® dataset creation

The EDC Solution meets:

• Audit trial requirements
• All validation requirements
• 21 CFR part 11 standards
• Control access and data encryption requirements

Ascon Health biostatisticians are excellent scientists.

Our colleagues have top industry standards in study design and analysis services. Ascon Health has a reputation for delivering 100% on-time and with accuracy.

Our biostatistics and SAS services include:

• Clinical protocol development
• Sample size for clinical study design
• Biostatistical analysis plans
• Biostatistical analyses
• Clinical SAS programming for tables, listings graphs and FDA reports
• Integrated summaries of safety and efficacy (ISS / ISE)
• Clinical and biostatistical study reports
• Biostatistical consulting and publication support
• Support for DSMB and adjudicating committees

At Ascon Health Clinical monitoring is an integral part of ensuring data quality.

In our clinical trial execution model we integrate monitoring into all aspects of operations. Ascon Health has interacted with hundreds of clinical investigative sites and has strong relationships with all sites.

Our clinical monitoring team:

• Assists with site selection and qualification
• Assists with patient recruitment
• Performs monitoring visits (SIV, SMV, SCV)
• Has experienced CRAs (> 5 years of monitoring experience)
• Has an innovative regional monitoring grid
• Focuses on study specific training methodologies
• Provides remote data access to CRAs for study related data

Project management at Ascon Health is an art that is fine tuned for each clinical project.

Our project managers lead teams that have the expertise, commitment and tools to deliver on clinical programs.

We offer an on target, on time and on budget approach with:

• Experienced project managers (10 yrs exp)
• Responsive and talented project teams
• Clinical Reports that meet pharmaceutical and biotech client needs
• Strong clinical site communication plans
• Daily snap-shot of clinical study status online
• Planning and conducting investigator meetings

At Ascon Health medical writing is focused and integrated with biostatistics.

Our medical writing team pays tremendous attention to detail while developing documents for submissions to FDA, scientific journals and clients. The team presents study results clearly, accurately, and in the proper context while adhering to FDA, ICH, and client guidelines.

Our experienced medical writers have:

• More than 150 abstracts/publications in peer reviewed journals
• Authored clinical study reports (CSR) for all phases I-IV
• Written protocols, study related material, investigator brochures, manuscripts, abstracts, posters and integrated summaries of efficacy and safety reports (ISS & ISEs)
• Successfully developed publication strategies that tie a clinical study to the potential marketing messages

At Ascon Health our regulatory approach is both strategies & tactical.

We have an accomplished clinical regulatory strategy team. Its team members have developed sound and approvable strategies with regulatory agencies for drug and biologic development.

We offer a team that has :

• Interacted with the FDA and other international regulatory agencies - including Medicines Control Agency (MCA), and Therapeutic Goods Administration (TGA)
• Taken products from concept to market
• Developed strategies to cut time to market
• Strong understanding of GCP, GLP, GMP and other regulatory requirements

Ascon Health understands the importance of timely adverse event management.

To that effect we have :

• Experienced staff under the direction of a medical safety officer
• Dedicated 1-800 line for SAE reporting
• A 24/7 response availability for SAE data collection / follow-up
• Templates for writing detailed case narratives