Home About Us Services Why SPSOFT? Careers Contact Us SPSOFT

Home > Services > Clinical Trial Services > FAQs

Clinical Trial Services

FAQs

How Do I Start
How do I get started? How soon can you accommodate us?

Process

Let us know your experiences on Clinical Operation partnering.
Let us know about the experience of SPSOFT in CDM?
How do you serve on Biostatistics?
What about the Medical Writing experiences?
Do your CDM operations meet the CDISC standard?
Is online data viewing available?
How data is transferred back?
Are data backups and archival taken care off?
Do you provide training to our staff?
Why should we outsource to SPSOFT?

Features
Does your staff sign Nondisclosure and confidentiality agreements? (NDA/CDA) Does "SPSOFT" comply with Regulatory requirements? Is my data secured? What is the measure taken for security of data? Do you have SOPs for DBA?

Payment
What are your pricing structures? How would we be billed?

Support
What are your support services? How is the communicating system? Where are your offices located?

How Do I Start
1.	How do I get started? Just send email to contact@spsoftindia.com. This email reaches out to a group of SPSOFT associates who would respond back to the enquiry.
2.	How soon can you accommodate us? Immediately / as per your needs.

Features
1.	Does your staff sign Nondisclosure and confidentiality agreements?(NDA/CDA) Yes, all our staff needs to sign and adhere to the Nondisclosure and confidentiality agreements, prior to joining us.
2.	Does "SPSOFT" comply with Regulatory requirements? SPSOFT adheres to 21 CFR Part 11, ISO, HIPAA regulations, and ICH-GCP guidelines.
3.	Is my data secured? SPSOFT is in the medical process outsourcing business for over a decade now. We have a HIPAA compliant system in place with controlled and restricted data access and strict maintenance of computer log/audit trails. Security measures at SPSOFT are very stringent to avoid and data theft or misuse.
4.	What is the measure taken for security of data? Some of the security measures followed is: Confidentiality agreements, Firewalls and Antivirus software, Password protected systems, Training on security, Offices guarded by security personnel, Detection of security breaches, access control etc. We have policies and SOPs created, maintained and updated on Data Security, Data Archiving, Data Retrieval, Business Continuity, and Disaster Recovery.
5.	Do you have SOPs for DBA? We have Process profile, SOP and guidelines for DBA. These are created and updated timely.

Process
1.	Let us know your experiences on Clinical Operation partnering. We have partnered services on Clinical Operations across various therapeutic areas in Protocol Development, Clinical Trial and Site Management, Clinical Trial Monitoring, Patient Recruitment, Quality Assurance, Regulatory Submissions.
2.	Let us know about the experience of SPSOFT in CDM? We have an in house CDMS – Oracle Clinical 4.6-RDC with TMS. Our team of experienced professionals is conversant with Oracle Clinical, ClinTrial, InForm, MedDRA, WHODD etc for data management and coding, also flexible enough to adopt new software and relevant systems.
3.	How do you serve on Biostatistics? We serve with Sample size calculation, SAP designing, Table, figures, graphs and listings, Statistical report writing. We have statisticians trained on E9 with a cumulative experience of 7 years. We use SAS 9.2 for our biostatistics services.
4.	What about the Medical Writing experiences? We also serve on Medical Writing for PSUR and CSR. Our medical writers are E3 trained. They are experienced on report writing for regulatory submission and publications across varying therapeutic areas for approximately 5 years.
5.	Do your CDM operations meet the CDISC standard? Our CDM process is 70% CDISC compliant. We follow 3.1 SDTM. Our annotations are as per the CDISC standards. However we are unable to follow same with the variable name, since OC4.6 allows only 8 characters.
6.	Is online data viewing available? SPSOFT uses a secure site (SFTP) to post CRFs, tables, listings and reports. Clients log in to the site with a password as provided by SPSOFT and may download or upload data to our file server; additionally specific customers needs can be discussed and worked upon. We also use Citrix as a terminal port for sponsor access.
7.	How data is transferred back? Data will be transferred to the client as per client’s specification in the format required by client systems. As needed, programs will be written and validated to produce the custom data transfers. Prior to any official electronic data transfer to the client, a test transfer will be provided in order to confirm that the format of the data files matches the client specifications and that the transfer process is error-free. Each of these transactions would be conducted via secured web area.
8.	Are data backups and archival taken care off? SPSOFT regularly backs up the clinical data per SAN/NAS technology. Backups that are stored both on and off-site in an appropriate secure and media safe environment enable speedy and accurate retrieval of the data.
9.	Do you provide training to our staff? Yes, we do provide training to your staff on how to use various applications.
10.	Why should we outsource to SPSOFT? SPSOFT is where the rivers of intellect, technology and application converge into the sea of customer satisfaction. As we have robust IT infrastructure in place to ensure complete accountability of the data being processed with validated 24 × 7 physical and data security, redundant power and internet connectivity along with experienced professionals required for Clinical Research. This reduces cost and time on IT infrastructure and support providing quality deliverables. SPSOFT concentrates on the theory of AACDM- Accelerated Authentic Clinical Data Management. The concept means reduced submission time and thus saving dollars. We have created macros for the updates and reuse of the safety reports. We have in-house CDMS – OC 4.6 – RDC with TMS. SPSOFT assures adequate staffing during the peak workflow on multiple projects. We are a partner by choice and offer our customer the same rather than as a vendor.

Payment
1.	What are your pricing structures? We will work with your facility to develop the most cost effective plan while ensuring the highest level of quality service. Please contact us at contact@spsoftindia.com for more details.
2.	How would we be billed? The billing would depend on each project. And can be discussed on each project by project basis. Please contact us at contact@spsoftindia.com for more details.

Support
1.	What are your support services? We provide 24x7 technical and application support services. For clinical studies we can provide Geo wise coverage depending on the requirements.
2.	How is the communicating system? We provide email teleconference, WebEx, Videocon support for better, clear and timely communication with clients.
3.	Where are your offices located? We have our headquarters at Pune in India and sales office in US.