ECRON ACUNOVA
 
 
 
Clinical Data Management, Biostatistics and Medical Writing
 

Clinical Data Management, Biostatistics and Medical Writing

 
   
We provide comprehensive clinical data management, statistical programming, bio-statistics and medical writing services for all phases of a clinical development program. This includes managing data for pharmacovigilance and PK/PD services. Our focus is to expedite the regulatory submission process and shorten timelines through innovative thinking and uncompromising quality.  
     
     
Our Team

Our team is drawn from leading pharmaceutical companies across the world and brings extensive global experience to every assignment. It consists of graduates and post graduates in medicine, pharmacy, engineering and science with years of experience in medical affairs, clinical data management, programming, biostatistics, medical writing, and project management. All functions work closely to ensure timely project delivery.

Data management, statistics, and medical writing services are offered on a global delivery model. Client contact experts are based close to client geography, while service production may be performed from Bangalore and/or Frankfurt as a cost efficient collaboration of expertise.

Our Expertise

Our expertise covers a broad range of therapeutic areas, data management technologies, statistical methodologies and various types of regulatory documents. The team members are experts in study design, managing and analyzing data from safety, efficacy and epidemiological studies. We participate in data safety monitoring boards and interact with various partners, including sponsors, health authorities, and other CROs.

Service Offerings

Consulting and Project Management

:
Clinical development plan, study design, monitoring, project management, drug safety management, scientific and medical as well as regulatory advice.

Laboratory Data Management

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Sample analytics for lab data, device interface with LIMS and automated result transfer, electronic data transfer in HL7, ASCII, CSV formats, lab and clinical data integration on any standard LIMS and CDMS. Similar scope is offered for PK/PD lab, Imaging core lab, & ECG core lab.

Coding and Dictionary Management

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MedDRA and WHO-DD coding, dictionary updates and maintenance, standard coding software (Thesaurus Management System TMS).

We use Thesaurus Management System integrated in the CDMS platform for both OC and in house EDC for coding including ATC classification. All versions of dictionaries of MedDRA and WHODDE are available for coding - AE/ADR, Indications, medications and surgical procedures. Coding is also available as functional service.

Clinical Data Management

:
CDM activities are performed using In-house EDC, Oracle CDMS and Medidata Rave, MARVIN. We provide full-service and functional services of hosting CDMS, database design and maintenance, database customization, data entry, data validation, medical coding and data standardization (CDISC).

Trial-In EDC – Comparable to any global EDC system in features and compliance. Deployed in virtual environment allows to scale the resources dynamically .Flexible in workflow, optimal customization reduces the application overhead thereby enhances the cost optimization & speed in delivery. Cost effective EDC solution for early as well as late phase studies. Good collaboration with sponsors/providers for application accessibility and integration. Flexibility in reports and listings to keep the study status up-to-date. Capable of handling different languages – question labels, instructions and help texts and can be extended to handle query text in regional language.

Biostatistics

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Statistical planning and sample size calculation, statistical analysis plan, statistical programming and analysis, SAS datasets according to sponsor’s or CDISC specifications, integration of databases, electronic data transfer, statistical reports and summaries, meta-analysis.

Pharmacovigilance

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Periodic safety update reports, CIOMS on web, literature review and medical narratives, signal detection and trend analysis, medical monitoring. Maintenance of safety data using our ARGUS system.

PV during a study as well as Post-Marketing service are offered.

Medical Writing & Regulatory Submissions

:
Protocol preparation, integrated report writing (ICH E3) electronic submissions, data review for specialised therapy areas by clinicians, sponsor-specific formats for reporting, safety summaries and narrative writing, literature survey, scientific publications and presentations.
  Our Software

Oracle Clinical


for data management and coding (Thesaurus Management System), processing both eCRF and paper CRF. Experience in RAVE, MARVIN & other platforms

SAS (Statistical Analysis System)


for data handling (import, export, transfer to sponsor), statistical analysis and reporting

Dictionaries


MedDRA, WHODD



WinonLin


For anlysing clinical and analytical data from PK/PD studies we deploy industry std software.

Reports


eCTD

software compatible to global regulators

ARGUS


for maintaining, reporting, and analysing

safety data

.


Quality Management

Each study is supported by our integrated quality management systems that ensure the use of standardized processes, technologies and training. Detailed SOPs describe content and responsibilities as well as procedure and quality measures for all tasks. Our processes and software are fully compliant with 21 CFR part 11 regulations. We continuously capture and analyse performance metrics on various CTQ (Critical To Quality) attributes to ensure the success of your program.

Our processes are ISO 9000 certified. Key establishments have undergone USFDA or EMA or a major regulator’s inspection and found compliant. Many study sites in several countries have undergone regulatory audits on studies monitored by us and found GCP compliant.

Archiving

In agreement with the sponsor the database will be locked. Together with a data handling report all data will be archived and transferred to the sponsor as SAS datasets or any other file format at request.


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Clinical Data Management, Biostatistics and Medical Writing
Our Team
Our Expertise
Service Offerings
Our Software
Quality Management
Archiving
 
 
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For further information, please email:
cdm@ecronacunova.com
EUROPE
biometrics@ecronacunova.com
 
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