Best practice for reliable data

Data quality influences the outcome of your clinical study.

The Data Management team of Assign DMB consists of experienced members with expert knowledge to help that data are complete, valid and reliable. 

Working closely with your team, we deliver high-quality results in compliance with regulatory standards and guidelines still coming up to your demands and expectations.

By observing the rapidly changing technology we constantly improve our working processes and services.

Data Management services include:

• Preparation of Data Management Plans
• Database Design
• Electronic Data Capture in various EDC systems
• User and Site Management
• Data Entry of Paper CRFs
• User Help Desk
• Status Reports
• Data Validation and Query Management
• SAE Reconciliation
• Medical Coding
• Integration of External Data
• Management of Data Review Meetings
• Preparation of CDISC SDTM Data Sets

Transform data into knowledge

Biostatistics is the summarizing part of a clinical study.
Our biostatistics team is coping with the analysis, evaluation and interpretation of data gathered.

To give generalized data a proper and meaningful interpretation, biostatisticians need to understand the generic construct of data and require a wide range of mathematical knowledge.

Being involved in ongoing processes to improve the quality of scientific inference, our biostatisticians are experts in transforming data into knowledge.

They use their various skills and are teaming up with experts within and outside the company to help answering research questions and to deliver profound scientific evidence.

Biostatistical services include:

• Sample size calculation and study planning
• Supporting the statistical part of the Clinical Study Protocol
• Preparation of Statistical Analysis Plans
• Management of Data Review Meetings
• SAS® Programming
• Conduct of Interim and Statistical Analyses
• Preparation of the statistical part of the Clinical Study Report
• Preparation of Analysis Data Sets (ADaM)

Safety First

Learnt from real tragedies during drug development in the past, patients’ safety is the very first priority in a clinical study.

Keeping this in mind, the pharmacovigilance department at Assign DMB provides widespread services related to safety management. Apart from monitoring patients’ safety, we supervise the safety of medicinal products. This helps to understand and prevent drug-related problems.

The pharmacovigilance team works in close collaboration with investigators, regulatory authorities, independent ethics committees, institutional review boards and sponsors. Our focus is on the collection, assessment and reporting of adverse experiences related to medicinal products in compliance with national and international laws and regulations.

The goal of our pharmacovigilance activities is to assist you in optimizing the safe and proper use of medicinal products to establish the safety profile of a drug, in order to improve the patients’ health.

Pharmacovigilance services for medicinal products or medical devices include:

• Preparation of Safety Management Plan
• 24/7 Safety Desk
• SAE Management
• Data Entry in Safety Database
• Query Management
• Expedited Reporting (SUSAR Management) including
  EudraVigilance Reporting
• Annual Safety Reporting (DSUR)
• Participation in Data Safety Monitoring Board Meetings

Capture ideas in words

Clinical studies are subject to strict regulations; therefore it is of utmost importance to provide standard-compliant documents.

Assign DMB’s Medical Writers have experienced skills in authoring and designing well-structured documents in compliance with ICH guidelines and regulatory requirements.

By cooperating with Project Managers and with our internal teams of Data Management, Biostatistics and Pharmacovigilance, we deliver accurate documents of highest ethical and scientific standards.

Medical Writing services include writing of:

• Clinical Study Protocols and Amendments
• Patients Safety Narratives
• Statistical Analysis Report
• Clinical Study Reports
• Standard Operating Procedures

We manage your oversight

Sponsor oversight of any trial related duties and functions is a GCP requirement.

Our foothold in Data Management and Biostatistics predestines us for overseeing your trials from a different angle by using area specific tools. Combining this advantage with our usual commitment, proactivity and strong capability to focus on what is really important makes us your ideal partner for your clinical trial.

Our lengthy list of possible partners gives us flexibility in selecting the ideal vendors for your specific needs.

Oversight services include:

• Vendor selection
• Vendor management
• Contract management
• Protocol Deviation management
• IMP/Lab sample management
• Vendor Oversight Plan
• CTMS management
• TMF management