Data management

• Who we are
• Clinical Data Management - Systems and Processes at its best
  • Data Management with Oracle Clinical
  • Data management with Clintrial®

Who we are

• Qualified database programmers (at least BSc-level or equivalent) experienced in designing and implementing clinical trial databases and data validation programs
• Professional forms design specialist experienced in drafting CRFs and questionnaires
• Coding specialists to assist coding in standard and proprietary coding dictionaries such as MedDRA®, ICD-9-CM, HARTS, WHO DD, SNOMED, NCI-CTCAE
• Trained and experienced data entry specialists
• Altogether, more than 80 active users of Clintrial® 4 and Oracle Clinical 4.5® in data management and Study operations

Clinical Data Management - Systems and Processes at its best

Accovion Clinical Data Management Flexibility

With a total of 80 experienced clinical data management systems users, Accovion can complete your clinical data management requirements according to your data management SOPs or according to Accovion data management SOPs.

Over the years, we have refined and continuously improved our data management processes to deliver the utmost in quality and data efficiencies carried out on

• Sponsor CDMS (Clintrial® or Oracle Clinical®; e.g. via Citrix-Server) or
• Accovion CDMS (Clintrial® 4.5 or Oracle Clinical® 4.5) fully validated and assessed to 21 CFR Part 11 compliance.

Systems and scope of Accovion Data Management services

Our systems and services are based on industry recognized standards and technology platforms to ensure that even the most challanging data management activities are efficiently and effectively addressed. Activities and services such as,

• CRF design using proprietary Bookmaker software or Adobe Pagemaker® or InDesign®
• Ready to use CRF-CDISC-SDTM modules are available incl. annotations with SAS labels etc.
• Design and implementation of clinical trial databases in Clintrial® 4.5 and Oracle Clinical® 4.5 (e.g. using sponsor or CDISC-SDTM data dictionary)
• eCRF technology with third-party products such as InForm® Architect (PhaseForward)
• Electronic patient recorded outcome (ePRO) technology with third party products such eDiary (CRF)
• Capacity to process more than 40,000 CRF pages per month via independent double data entry
• Capacity to scan and index all CRF pages for immediate availability to the full study team
• More than 70 electronic data transfers per month (e.g. lab data, device data)
• Unified management of coding dictionaries, synonym tables and code lists with connections to
• Clintrial®, Oracle TMS®, and SAS® with the ability to extract any version for coding and data analysis
• Setup of coding dictionaries, synonym tables and coding algorithms using Clintrial® Classify or Oracle TMS®
• Auto coding with Clintrial® Classify or Oracle TMS® with or without synonym tables
• Coding specialists to assist coding in standard and proprietary coding dictionaries such as MedDRA®,
• WHO DD, NCI-CTC, SNOMED, ICD-9-CM, HARTS, NCI-CTCAE
• Proprietary Clintrial®-SAS®-interface SASenv to transfer data on a routine day-to-day basis from Clintrial® and Oracle Clinical to SAS® for consistency of clinical trial database and statistical analysis datasets

Flexibility and Customized Services

Accovion offers CDM services with a maximum of flexibility: Sponsors may contract all or a portion of their CDM workload to Accovion. Our infrastructure and clearly defined system interfaces provide us the flexibility to define work processes between a sponsor system and our environment as well as seamless integration into sponsor-defined processes. Some examples of this flexibility are:

• Design of DB on sponsor CDMS
• Programming and/or testing of validation rules on sponsor CDMS
• Data entry into sponsor protocol on Accovion CDMS
• Scanning and indexing of CRF pages on sponsor imaging system or Accovion system
• Data coordination split between sponsor and Accovion
• DB setup and data coordination on Accovion CDMS and export of data into sponsor's repository database.

In a recent mega trial in the US and Europe Accovion has setup the DB, data entry and data coordination was split between US (Quintiles) and Europe (Accovion), data analysis was done by Accovion.

Our experience makes a difference

• More than 20 successful submissions to FDA or EU authorities in the past 10 years.
• Clintrial® users since 1994, used in more than 100 phase I to phase IV studies.
• Oracle Clinical users since 1999, used in more than 30 phase I to phase III studies.
• Most employees with more than 10 years of experience in clinical development.

Data Management with Oracle Clinical

Accovion and Oracle Clinical

Accovion offers a complete range of Clinical Data Management (CDM) activities using one of the most powerful clinical data management systems: Oracle Clinical (OC).

With over 6 years of system and user experience, our current data management version OC 4.5 is fully validated and 21 CFR Part 11 compliant. A total of 20 Oracle Clinical users, most of them with more then 10 years of expertise in clinical development, are experienced in working with the system and its related processes. The following tasks are performed by Accovion using Oracle Clinical:

Randomization

The Oracle Clinical randomization tool or our proprietary Rando system can be used to generate the majority of possible randomization plans. Coated lists containing the treatment information can be provided.

Database Set-Up

Set-up includes the definition of the database and derivation/validation programming using a wide range of standard modules available in the Global Library of the system. Together with the data collection modules a broad set of standard rules is available. The standard library includes the CDISC-SDTM tables and items. These libraries allow for a faster DB setup and very high quality.

Data Entry

In-house data entry is performed by experienced data entry personnel. If appropriate, the Oracle Clinical eRDC tool can be employed at the investigational site.

Coding

The Oracle TMS (Thesaurus Management System) version 4.5 is used for coding medical information initially entered in Oracle Clinical as verbatim terms. Different versions of dictionaries can be used to fulfil the sponsor's needs.

Coding specialists perform the coding in the standard and proprietary coding dictionaries MedDRA® and WHO DD.

Discrepancy Handling

Experienced Data Managers handle the queries in the Oracle Clinical discrepancy database. Automated Data Clarification Form (DCF) generation is used. This allows for fast processing, tracking, and solution of queries according to ICH / GCP, following sponsor SOPs or Accovion SOPs. The DCFs can be processed by email (pdf), fax, or mail.

Laboratory Data Handling

Oracle Clinical offers a special tool to handle laboratory information in a most effective and convenient way. Labs, lab parameters, units and ranges are managed within the system. Normal and extended ranges can be assigned to each lab result and can easily be modified during the course of the study. Electronic lab data transfers can be defined in cooperation with central lab(s) and performed on a regular basis.

Data Extract

Extraction of the data is performed in a standardized manner using SAS/Access to Oracle

Flexibility

Accovion offers CDM services with a maximum of flexibility: sponsors may contract out all or only a part of their CDM workload to Accovion. Accovion offers full integration with the sponsor's processes and systems. This flexibility is embedded in a validated environment, working either according to the sponsor's or Accovion's Data Management SOPs.

Data Management Clintrial®

Experience and Size matter

Since 1994, Accovion has been using Clintrial® in more than 100 phase I to phase IV studies. We have a total of 60 Clintrial® users, one of the largest Clintrial® user groups in Europe enabling us to competently deal with any workload neccessitated by a clinical study. No matter how the workload is distributed, the usual peak in workload before DB closure can be avoided. Our work has encompassed some of the most aggressive timelines with respect to database setup and edit check programming, data entry, sending queries, and closing of the database. Consistently, we have delivered quality data for our clients.

Some processing highlights this year:

• 40,000 CRF pages per month
• 70 electronic data transfers per month

Clintrial® 4.5 Validation and Security

Extensive validation according to GAMP level 4 was completed this year. 21 CFR part 11 compliance has been documented, e.g. our audit trail starts at data entry. System, procedural and organizational measures are in place that guarantee the highest level of security possible as servers are hosted in an ISO-9001 certified data center supported by the highest possible physical data security, backup & recovery procedures. Our internal IT department manages Clintrial® administration separated from study teams.

Sponsor auditors have been continually complimentary of the level of security, ensured integrity & confidentiality of data as well as of the quality and amount of validation completed. Online read access for sponsors via l-review can be set up using a dedicated Clintrial® server and Citrix Secure Gateway Technology (personalized role-based access).

Clintrial® 4.5 CDISC and DB setup

Accovion is a registered CDISC solution provider. Based on CDISC-SDTM (as recommended by FDA) we have build a data dictionary covering submission datasets. Additionally, we have created annotated CDISC CRF modules. Both of these investments allow for

• a faster DB setup and
• full compliance with CDISC-SDTM standard.

We have also implemented CDISC-Lab model incl. LIONC codelist. We are well prepared to receive data in XML using CDISC format.

We can set up the DB according to Sponsor's Clintrial® protocol, project data dictionary, codelists and other requirements.

Two alternatives have to be investigated: Set up of a sponsor specific Clintrial® instance (including validation) or inclusion of protocol, data dictionary, and codelists within our validated standard Clintrial® instance.

Data Management on Sponsor's Clintrial® system

Accovion has a wide range of experience in working on the sponsor's own systems, following sponsors SOPs, standards and processes. This includes database programming, testing of edit checks, coding, creation of project data dictionaries etc.

Integration of electronic CRF usage

Several studies in the past have included eCRF usage, e.g. patient recorded outcome (ePRO) on PDA. We have supported the setup and have uploaded these data on a regular basis into Clintrial®.

Coding options with Clintrial®

Throughout Accovion we are using a unified system for managing coding dictionaries, synonym tables and codelists with connections to Clintrial®, Oracle TMS, Argus Safety and SAS. We have the ability to extract any version for coding and data analysis and any combination of dictionary and synonym table can be used.

Standard setup includes autocoding with Clintrial® Classify with or without synonym table, in MedDRA®, WHO DD, NCI-CTCAE, SNOMED, ICD-9-CM and HARTS.