- Principal focus on Sponsors, then CRO’s
- Maintain strong relationships with existing clients, with high levels of delivery to generate repeat business.
- Identify and develop new relationships with Sponsors and CRO’s that we are not currently working with. Undertake Capabilities Presentations and get MSA’s agreed.
- Focus on areas we are already good at and with excellent metrics, whilst developing database and metrics for new areas.
- Concentrate on high value work that is easier to undertake e.g. by reference to patient access, experience, comorbidities, etc.
- Be mindful of developing capacity through expansion of MERC Sites to cope with workload. Traditionally 8 good studies (high volume, value and achievable), annually seem the right level, so BD has to focus on getting the best ones that fit our business aims. Our reactive workflow has been strong hence less need for an all out proactive approach.
- Provide a strong, value driven proposal through blended rates and a thought out delivery package.
REGULATORY AND FEASIBILITY
Our Feasibility and Proposals Team is led by Melandri Eloff, Head of Feasibilities and Proposals
- MERC has a central dedicated Feasibility Team
- Working in close partnership with sites and our senior management team
- Early rapid response from sites and contacts for feasibility questionnaires
- 3 – 5 days for initial list of sites and estimated enrollment (majority were responded to within 1 day)
- 10 days for full budget and proposal for awarded studies.
We Are Looking To
- Streamline the feasibility process
- Proceeding straight to site selection
- Providing capabilities slides for each Therapeutic Area
- Using a Top Down approach with Sponsor/CRO sales teams
South Africa– IEC
- Mixture of 2 x private IEC’s for private sites, academic IEC’s for University sites and
- Submission made monthly on scheduled submission dates, followed by an IEC meeting two weeks later
- Approvals received between 2-4 weeks following the scheduled meeting (If no
- Once IEC approval is received, client must submit Material Transfer Agreement to the DOH to obtain Export Permit for lab samples (3-4 weeks for approval). During 2018 we have experienced a huge backlog in Export permit approvals that resulted in a delay in approvals, but turnaround time has improved since.
South Africa – IEC
- Scheduled Meetings every 2 months. Submission is 1 month before meeting date. Application reviewed and queries raised before meeting. Additional study related queries can be raised after meeting.
- 3-4 months after submission approval can be expected. (Since beginning of 2018, SAHPRA took over from MCC and an improvement in turnaround time is evident.)
- Clinical trials require a SAHPRA and IEC written approval to start
- SAHPRA and IEC submissions occurs in parallel
BUDGETS AND CONTRACTS
Turnaround time: 5 – 10 days for full costing, subject to information provided. Ballpark budgets may be quicker.
We provide a central budget with blended rate in our standard template; Sponsor budgets typically don’t include line items for our model & the additional activities undertaken to deliver our premium services.
- Our focus is principally driven by high delivery
- Costs per patient are lower than other SMO’s
- We’ve aligned our budget presentation so its a familiar format, offering transparency
- We offer flexibility and can move costs within the budget to meet client needs
- We have a pragmatic approach to risk share strategies
Turnaround time: typically 2 weeks, subject to sponsor timelines, negotiation of budget and contractual terms.
Our preferred process is one central contract (within an overarching MSA) covering all sites involved.
- Provides maximum efficiency and facilitates rapid start
- We approve the contract within 24hrs of budget approval
- Sponsor contract requirements can be accommodated
- MERC takes care of all our sites contracting via our own robust contracting structure and processes, thereby saving CRO resource
- Amendments are easily managed
- Central invoicing and we pay the sites!
- Metrics set up on a national study basis in line with Sponsor expectations.
Our Programme Management Team is currently led by the Project manager assisted by Site Managers.
- One point of contact for Programme Management across all MERC sites
- Central ‘Essential documentation’ collection to expedite start up and reduce admin burden
- Central EC management to facilitate speedy submissions
- Central oversight on study level training and follow up
- Supplies and SIV coordination
WE HAVE OPERATIONAL PROCESSES IN PLACE THAT ENSURE PRIORITIZED START UP OF OUR SITES.
- Continuous lessons learned and mitigation across multiple MERC sites
- Patient, Site and client centric approach to study conduct
- Weekly reports to provide oversight of all up front activities
- Management of conversion rates throughout the recruitment funnel to ensure low fail rates
- Support KPI’s for data entry, query resolution, etc.
- Escalation point
Maintenance And Close Out
- Manage re consents and protocol amendments
- Support database lock to ensure deadlines are met
PM, TRAINING & DEVELOPMENT & QUALITY DEPARTMENTS WORK TOGETHER TO ACHIEVE CLIENT SATISFACTION
- Internal audits Focused on inspection readiness – RED FILE
- Study vendor and site level audits
- Operational Compliance visits performed regularly by Quality Defenders.
- Review of monitoring reports to assess trends FU Letter Training Sessions
- Management of Quality Issues (QIs) (root cause analysis, CAPA process)
- Supporting client audits/reg inspections
SOP Management And Mandatory Training Licenses Management
- 75 SOPs issued to date and controlled Docs (Standardisation of processes)
- Training file Management (Centralized GCP, IATA & Anti Bribery training)
- Mandatory training licenses are issued for GCP, IATA, and Anti-Bribery courses (completion ensured within required timescales)
Experienced Teams And Dedicated Data Coordinators Who Work Full Time On Data Entry.
- DCs are trained and experienced in all commonly used eCRF and safety reporting systems
- Timely data entry and rapid query resolution metrics to monitor d ata entry
- Close management of database locks enables timely sponsor data analysis