FSP Solutions

Cytespace is the first to bring a ‘Collaborship Model’ for Pharma & CROs to facilitate expansion of their Clinical Research business growth by enabling them to expand their footprints in India & other geographies. At Cytespace we are cognizant of the need for technological innovation & optimization in Clinical Research, thereby bringing in enriched clinical acumen to enable patient centric data solutions. We drive successful collaboration models and practically attain strategical solutions.

Our FSP approach focuses on providing customizable solutions to clients and CROs to meet their requirements.

We are pioneers in providing end-to-end solutions but not limited to Data Management, Medical Coding, Database Programming & Validation, Records Management, Study Start-up, Review of Essential Documents, Biostatistics and Statistical programming, Centralised Monitoring, Safety & Medical Writing, Regulatory Affairs, Learning & Development, Back-end-activities (Investigator Grant Management, Payroll Management, HR Generalist, IT Solutions & Support).

We perform holistic Clinical Data Management activity with enhanced integration of data science and solutions delivering quality work to our customers and sponsors. Our Expertise includes paper and electronic case report form (CRF) design, clinical trials database design and programming, data standards, system implementation, data acquisition, data integration into the clinical trials database, data review, validation, coding and database finalization.

Highly Talented and innovative team at Cytespace has proven results in catering to the Clients and CRO’s need with global standard Quality.

Medical coding is an integral part of clinical data management and is the first step to make the data structured for analysis. For this purpose, standard coding dictionaries play an important role. We have experts who are versatile in coding, maintenance and management of Standard Dictionaries such as MedDRA, WHODrug etc.

Database Programming and Validation:

We have a well-equipped programming and validation team which provides services like Database Development or setup, Edit Check Programming, Integration and Randomization setup, Local Lab module setup, eCRF and Edit Check Validation.

Documentation serves as a source of the work we do and our Records Management team ensures standard and timely storage & archival of study documents. Our Records Management tools are of high standards and are compliant with Regulatory requirements

Study wise start up activities are managed by our experienced team. The team ensures faster SIVs at our sites, collection & follow-up of all essential documents required from the site/sponsor/CRO and provides proactive communication on the upcoming EC meetings sponsors/CROs. The CAT team will track the time of Site selection confirmation to SIV and this is one of our metrics parameters which is assessed for all studies in start-up.

Biostatistics remains an integral part of our services and solutions. Statistics is at the heart of every clinical study—driving study design, protocol development, clinical data collection, analysis and reporting. From study inception to delivery of the Clinical Study Report, our skilled biostatisticians are involved to increase efficiencies at every phase of clinical drug development. Our in-house validation and quality control processes eliminate the need for corrections from our client counterpart and we deliver clinical trial results that are scientifically accurate, validated and reproducible.

Our team ensures we follow industry standards like Clinical Data Interchange Standards Consortium (CDISC) and mapping SDTM into ADaM.

We have the perfect integration of SAS programming and statistics to create the magic concoction of Statistical Programming, turning un-interpretable data into something meaningful to make informed decisions, improving patient safety, demonstrating drug efficacy and getting drugs to market faster. Our fast, flexible, and proven statistical programming framework comprises best practices and custom macros built by our experienced team of Statistical Programmers and SAS experts.

We offer a range of statistical programming services:

  • CDISC and ADaM Submission-ready Dataset Development and Quality Control for Submission Compliance
  • Analysis Dataset Development and Quality Control
  • Tables, Listings, and Figures Development and Quality Control
  • Interim Analysis Support