Data Management & Statistics

Data Management & Statistics

At ProRelix Research we are a team of experienced people who are well aware of 21 CFR, HIPAA, ICH GCP compliance to provide clinical data management services. Our statisticians have extensive experience in various phases of clinical trials and different therapeutic areas. Working on a project, our team sees each study through from protocol and CRF design to statistical report.

  • Perform data management (Study Set Up) activities

  • CRF Designing/Tracking

  • Test script and UAT

  • Data Entry and Verification Data Review/Query Generation

  • Discrepancy Resolution

  • Preparation of mock CRF, CRF completion Guidelines (CCG)

  • Preparation Data Validation Specifications (DVS), Study – Plan Specifications (SPS) etc

  • Statistical Analysis per Protocol

  • Final Trial Reporting

PRORELIX RESARCH provides traditional clinical data management solutions as well as an Electronic Data Capture (EDC) and Electronic Patient Reported Outcomes (ePRO) approach, giving flexibility in data management solutions while always maintaining high standards for data quality and timeliness.

In addition to full-service clinical research trials, PRORELIX RESEARCH supports many stand-alone and functionally-based biometrics projects. Clients rely exclusively on our staff to manage all biometrics aspects from rapid data entry to final trial reports. Our experience allows us to make recommendations on the most efficient and cost-effective approach for any clinical research trial.

The PRORELIX RESEARCH Clinical Data Management team has built up extensive hands-on experience with several data management systems over the past years. Therefore, our Data Management team is able to offer our clients the right solution for their project.

As a result and similar to all other areas of our operations, PRORELIX RESEARCH is able to offer the flexibility that our clients desire and require.

Often our clients require PRORELIX RESEARCH to manage all Biostatistics aspects of their projects from protocol development and sample size calculation to final study report. Our experience allows us to identify the most efficient and cost-effective approach to completing your clinical trial.

The PRORELIX RESEARCH philosophy is always to leverage our experience and expertise to support each and every client regardless of their size or project scope. This philosophy ensures each and every assignment receives the same dedication, ownership, and team.

PRORELIX RESEARCH Provides the Following Biostatistics Services

Consulting

  • Regulatory interaction – FDA/ICH/EMA and advice (including CDISC integration)

  • Process improvement

  • Statistical support on-site

Design

  • Sample size calculations

  • Randomization

  • Protocol development and clinical study planning

  • Statistical analysis plan (SAP)

  • Presentations of study design to regulatory agencies

 Clinical Data Management Services Company in India, UK and USA. Clinical Data MAnagement Services by ProRelix Research CRO.

At ProRelix Research in our clinical Data Management services in India, UK and USA we focus on Quality, Ethics and Well-being of the clinical trial subject throughout clinical trial. ProRelix Research offer Phase II to IV clinical data management services in compliance with 21 CFR part 11, HIPAA and ICH GCP. We provide quality Clinical data management that result in authentic, verifiable and accurate data.We believe in offering unique expertise in various therapeutic areas and provide services either as an independent team or working along with the client’s own management.We follow quality process to secure all the necessary steps of a clinical data management project run smoothly.

Clinical Data Management Services by ProRelix Research CRO

PRORELIX RESARCH provides traditional clinical data management solutions as well as an Electronic Data Capture (EDC) services and Electronic Patient Reported Outcomes approach, giving flexibility in data management solutions while always maintaining high standards for data quality and timeliness.

In addition to full service, PRORELIX RESEARCH supports many stand-alone and functionally-based biometrics projects. Clients rely exclusively on our staff to manage all biometrics aspects from rapid data entry in clinical trials to final clinical trial reports. Our experience allows us to make recommendations on the most efficient and cost-effective approach for any clinical data management project.

The PRORELIX RESEARCH Clinical Data Management team has built up extensive hands-on experience with several clinical data management systems over the past years. Therefore, our Clinical Data Management team is able to offer our clients the right solution for their project.

As a result and similar to all other areas of our operations, PRORELIX RESEARCH is able to offer the flexibility that our clients desire and require.

Often our clients require PRORELIX RESEARCH to manage all Biostatistics services aspects of their projects from protocol development services, CRF designing services or eCRF designing services and sample size calculation services to final study report preparation. Our experience allows us to identify the most efficient and cost-effective clinical data management services approach to completing your clinical trial.

The PRORELIX RESEARCH philosophy is always to leverage our experience and expertise to support each and every client regardless of their size or clinical data management project scope. This philosophy ensures each and every assignment receives the same dedication, ownership, and team.

Why ProRelix Research Clinical Data Management Services in UK

Since 2011 ProRelix Research has been supporting our clients with outstanding clinical data management services. The successful growth of ProRelix Research has been achieved by putting high quality and client focus at the heart of everything we do at clinical data management activities. We leverage our experience and expertise in drug development at the early stages of discussions with our clients to freely advise them on the optimal project plan. We then reach decision with each client on the scope of service, timelines and budget. ProRelix Research then commits to deliver CRO services on time and within budget – including our End to End clinical data management servicesguarantee. Our commitment to clinical data management services’ guaranteed delivery is unique in the clinical research environment which is otherwise notable for the routine occurrence of delays and cost overruns. Acting through Pharmaceutical, Medical Device Research teams, and with a comprehensive portfolio of services, we offer a flexible approach to ensure ProRelix Research optimally support the unique clinical study conduct needs of each client. This could mean providing regulatory consultancy to a small company at the early stages of development programme, through to provision of full services to a company performing an international mega trial to support registration of their product. Whatever the size and scope of the project, each receives the same level of attention to detail and commitment to delivery of a high quality service within budget and to timelines agreed.Advantages of ProRelix Research are Assured Study Startup Time, Assured Enrollment, Assured Database Lock Period.ProRelix Research provide clinical data management services globally and also with partner Connections for clinical data management services provider in UK, USA, Peru and South AfricaMarket Reach: Connected to Pharma, medical device, biotech and herbal clients for best clinical data management services in India and internationally.ProRelix Research receives clinical data management projects in UK from pharmaceutical, biotechnology, medical devices, herbal industries and universities as clients.We believe in offering unique therapeutic areas expertise in clinical data management and provide clinical data management services in UK either as an independent team or working along with the client’s own management. Our clinical data management therapeutic areas expertise is in Oncology CDM services, Cardiovascular CDM services, CNS – Including Pain Management CDM services & Psychiatry CDM services, Ophthalmology CDM services, Autoimmune / Inflammation CDM services, Endocrinology / Diabetology CDM services etc.

ProRelix Research Clinical Data Management services in India Recognition: ISO 9001:2015 Certified, Awarded as “Best CRO for Clinical Data Management in India”, “Certificate of Commitment” issued by Central Vigilance Commission of India

India Great Destination for Clinical Data Management and Clinical Research Studies

India has always been a hot destination to outsource or conduct clinical trials and outsource clinical data management. Many key factors of doing or outsourcing clinical data management and clinical research in India, make it a worthy place.It’s very logical for sponsors who are interested in selling their products to India’s 1.25 billion population, where demand for new medicines is increasing considerably. Approximately 17% of the world’s population and 20% of the global disease burden is in India.India has a huge patient pool who may be eager to participate in trials that would give them access to life saving drugs. Availability of infrastructure and skilled young manpower, English speaking and trained talent pool to manage clinical trials, and all this at a lower cost clinical trial and low cost clinical data managament. In recent time the licensing authority of India (CDSCO) has taken steps to fast track approvals for clinical trials and has also given more freedom and responsibilities to Ethics Committees.These key factors to outsource clinical data management in India give sponsors an opportunity of a competitive advantage of cost effective clinical data management.

 

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