Cytespace offers a powerful and scalable solution to deliver better efficiency, quality and patient recruitment to our global pharma customers, CROs and Investigators. Led by a pioneering team with global experience, Cytespace leverages its footprint across Asia and Africa to deliver superior study outcomes
With over 200 hospital partnerships supported by Cytespace professionals at site, Cytespace offers a unique service delivery model built on Quality-at-Site and regional Scale of operations leveraging standardized Processes and a proprietary Technology platform.
Cytespace has instituted standardized processes at each site that ensure quality at every step of delivery. Our business model enables this through a strong focus on training for site personnel combined with mentorship from experienced line managers and a central analytics team that can spot trends and trigger corrective actions.
Quality is measured and monitored using a variety of metrics at the study conduct stage of the trial. These metrics are drafted in consultation with the customer and reported at an agreed frequency to stakeholders including the PI. This articulation of the quality metrics in every project helps build a common view of what is required and expected.
Cytespace has an independent Quality Assurance (QA) team that supports operations across various business lines and geographies. The QA function supports the development and management of the Quality Manual, and all the SOPs that reside under it. Cytespace reviews the performance of its processes using the QA function via periodic internal audits and process reviews.
Cytespace has developed Standard Operating Procedures (SOPs) to ensure that our operations across sites are standardized in accordance with local regulatory requirements, principles of ICH GCP and industry quality standards. The SOPs are a subset of the overall Quality Manual that governs the role and responsibilities of each Site Solutions Executive (SSE) at site, Site Solutions Managers (SSMs), Central Analytics Team (CAT) and the processes around trial conduct.
Cytespace also has developed site SOP templates to support each of our sites. These include core areas including Investigator responsibilities, Informed Consent, Patient handling, Serious Adverse Event (SAE) reporting, Investigational Product (IP) management, and Document management, amongst others. Our staff support the site team in terms of customization of SOPs or upgrade from existing SOPs. This helps us ensure consistency across Cytespace sites.
Cytespace also supports the Ethics Committees at the sites, if requested, by providing guidelines and information about regulatory requirements, GCP training, guidance on protocol evaluation, SOPs and reporting requirements.
Our team includes Operational Training Faculty who are involved in the development, review and implementation of SOPs, as well as training the staff across the sites in the usage of SOPs and are experts in associated site training.
One of the key differentiators for Cytespace is the fact that the operation is currently spread over a vast geographic area and across several hundred people. This scale is unprecedented and has been made possible because of two specific pre-designed aspects:
There are multiple facets of the job at the site and Cytespace has created a career around site management for its staff. This long-term career progression possibility, coupled with specific training on a consistent basis, has proved that people prefer to work with Cytespace.
Cytespace has also deployed standardized annual appraisal so that each staff member understands how they are doing, and what they need to do to achieve their career goals.
Cytespace now has a talent pool across all levels of operations and management, who can further train new people and deploy process and technology even in trial naïve sites. This has helped in expanding the network in a consistent manner.
While building excellence in each site, Cytespace has also made the effort to build a network by connecting each of these sites with one another. There are many points of connection:
The DNA of the company is built around process management and continuous improvement. This is demonstrated by the focus around consistency and documentation at every stage of interaction. Two specific attributes of process excellence in this domain are:
This started off as a lessons learned database to document opportunities for improvement. The idea was to develop this into an on-boarding tool to SSEs in a new study. However, the tool has now evolved to become a self-study reference resource for SSEs who can first refer to it to address any specific issue they face before speaking with their line manager or peer.
The vision is to develop this database across multiple therapeutic areas, and to include experience of every project that is completed into the database to keep it current.
Cytespace strives to develop and monitor metrics for all key processes. This gives a baseline for comparing across all sites, and also serves as a quantitative measure of improvement across the processes.
Cytespace is also involved in an international effort to standardize on metrics for clinical trial conduct at sites, from across the world, and for sharing best practices in a community forum.
Cytespace currently uses point technology solutions for training and assessment, process management and quality tracking. All of this is deployed from a central location, and all solutions are cloud-based. This allows for a central change management methodology to be used for new versions and training. The vision for technology is to construct two inter-connected stacks:
To be deployed centrally, and used at sites and the analytics centre to build efficiency at the site for individual trials. These systems take care of calendaring of patient visits, tracking of progress of subjects through the trial and other Metadata about the trial.
The data from these systems allow for visibility of the conduct of the study at the analytics centre, and is combined with an SMS based alert system to be sent to subjects and staff at site to alert them about impending events in the study timeline.
The same systems will trigger invoicing and will track payments for all studies across all sites. The invoicing and tracking takes place centrally to allow for consistency of managing finances across each of the sites, and providing the customers a single point of accountability from financial aspect.
Will be deployed only at a central location and will harvest Metadata from each of the sites in the network. This decision system is a proprietary tool which will store historical data from sites, collate data from public sources and private paid sources around investigator capabilities and patient throughput in each site. The data into the decision system will be updated every time a project is initiated, and is closed out, and also on a six-month basis for all sites. This can be done on a regular basis because of the extensive network of sites where Cytespace has a physical presence.
This system will generate more accurate feasibility data for specific protocol variables, and also country assessments for broad therapeutic areas. This can be done across specific regions, or countries or across the entire Cytespace network.
Cytespace offers wide range of training programs to the Ethics Committees. Full Day EC workshops to byte size training on specific aspects like review of Research proposal, Review of Informed consent process, SAE review etc. is provided.
Cytespace provides GCP training to research professionals ranging from Study Co-ordinators to Doctors. Our training program includes discussion on real case scenarios, Quiz, role play etc.
We have strong presence at our 8 Cluster sites:
We are closely working with around 7 + studies at these sites from 2013 in various therapeutic areas.We have been supporting the sites in developing Research facilities and ensuring 100% compliance with the Site SOPs and regulatory requirements.
For each single study, a study team is constituted including the SSEs at Site, Respective Line Manager, CAT team and the Project Manager who serves as the single point of contact for the Sponsor/CRO. Weekly internal calls are conducted to track the progress of the study from Recruitment to close out. Recruitment strategies are assessed periodically to ensure that each site target is met. Expectation on timelines for completing source and eCRF are fixed and consistently tracked by the CAT team. Processes and checks are in place to confirm the site is ready for monitoring and resolution of Action items after the SMVs. The Project Manager also conduct regular calls with the Sponsor/CRO in a predetermined frequency.
Monthly metrics calls are scheduled and the team will assess the study status across all sites and proactive actions are decided and implemented for all studies.
100% compliance to all the above processes are tracked centrally through Cytestream
Database of potential patients are created well in advance for studies where retrospective cases can be considered. There are many studies where the First patient screening happened immediately after the site is activated. Various enrollment strategies are developed in consultation with the site team and the same will be tested in a predetermined frequency to confirm if the same strategy is working or else other strategies like referrals /conducting camps /adding more team members will be immediately implemented.
The site team is well educated and trained on the importance of Patient retention. Retention starts after the patient has been consented. Cytespace sites are awarded by the Sponsor for many studies including long term event driven studies for having 100% retention.
Cytespace has strong feasibility team who are contacted by the Sponsors/CROs for getting the feasibility information across sites in India. We have strong long term presence at few key Multispeciality Cluster sites with 8 -10 ongoing studies in both Govt and Pvt sector. Cytespace facilitate therapeutic area feasibility discussions with the Key Opinion leaders from these sites. Feasibility team give equal importance to the awarded and non-awarded feasibilities and the responses are provided within the timeline with accurate information. Site selection visits are well hosted by the sites and this ensures the completeness and adequacy of all essential document collected from the sites.
Cytespace has developed and maintained a detailed listing of investigators in the regions of operation. This listing includes basic information like experience and infrastructure available in various institutions, and also detailed information like patient through-put across various stages of progression. All of this information is collated from sites where Cytespace operates and has an agreement, as well as combined from information that is publicly available. This information is renewed every six months and maintained in the decision system.
There are specific indications where Cytespace has commissioned detailed studies and produced white papers for the operating regions. These include:
Using all of this historical information, Cytespace can conduct high level feasibility for an indication to judge which regions to conduct specific studies. Once a decision is taken about the region, a detailed protocol specific study can be conducted, with face to face meetings with investigators across a wide geographic area to establish feasibility for conducting the specific study. The advantage of a face to face meeting is to allow the investigator to spend quality time reviewing the protocol, their patient records and competing trial information to provide a more accurate assessment.
While accuracy of the information is important, Cytespace has established a framework for turning around these studies in a matter of days because of the availability of staff, on the ground in hospitals, across a wide geographic area, and who know the investigators OPD hours, operating hours etc. and can tap into their available time to get this study conducted.
Study wise start up activities are tracked by the Feasibility team. The objective is to have faster SIVs at our sites . The upcoming EC meetings are communicated proactively to the Sponsor/CRO and queries, if any from the ECs will be responded adequately on time to ensure that site is ready for SIV immediately after the Regulatory approvals. Collection of all essential documents required from the site and Sponsor/CRO will be followed up. The CAT team will track the time of Site selection confirmation to SIV and this is one of our metrics parameter which is assessed for all studies in start-up.
Cytespace provides regulatory support by offering a single point of contact for assessment of and further submission of regulatory documents to the authorities.
Cytespace has deep regulatory expertise and a network of consultants who can be brought in to support the creation and submission of the regulatory dossier in each country. The regulatory submissions need to be customized depending upon the type of product (device or biotechnology product or pharmaceutical product or nutraceutical), phase of the trial, countries involved in the trial, and number of patients/ subjects involved. We also support the biopharma sponsor in terms of preparation of any presentations that may be required to defend their regulatory applications.
Cytespace supports the submission of trial-specific documents for IRB/ EC review and approval as per the required formats for each site IRB/ EC. This includes centralized tracking of the IRB/ EC meeting schedule, requirements of each IRB/ EC in terms of documents/formats and number of copies, covering letters etc. We ensure timely submission, presentation and tracking of approval letters, quality checks to ensure that the approvals/ letters are as per the local regulatory requirement.
During the conduct phase of the trial, the central analytics team of Cytespace supports the sites in terms of notification of SAEs/SUSARs and annual status reports to the IRB/EC or the regulatory authorities as required. This reduces the effort for the biopharma sponsors/ CROs and also the sites as this is centrally managed across the the network of Cytespace managed sites.
The recent amendment in Drug and Cosmetic Act, requires Ethics Committees to register with Ministry Of Health (MOH) / Drugs Controller General of India (DCGI). Cytespace offers services to Ethics Committees (ECs) and provides assistance in relation to the registration/re registration of Ethics Committees. Following are the services provided:
Apart from the services listed above, we ensure that the EC is equipped with all required documentation before the NABH assessors visit the EC. Support the EC throughout the assessment and help in responding to EC on any non-compliance issued.